Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT02479412
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2015-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708431', 'term': 'velsecorat'}, {'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+46 31 7761000', 'title': 'Global Clinical Leader', 'organization': 'AstraZeneca AB'}, 'certainAgreement': {'otherDetails': 'If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Screening to Follow-up (these two examinations are up to 165 days apart)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (PBO)', 'description': 'Placebo for AZD7594 DPI once daily', 'otherNumAtRisk': 52, 'otherNumAffected': 17, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg', 'otherNumAtRisk': 34, 'otherNumAffected': 13, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg', 'otherNumAtRisk': 34, 'otherNumAffected': 9, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg', 'otherNumAtRisk': 34, 'otherNumAffected': 12, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Hepatosplenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Anaemia vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 µg vs. PBO', 'categories': [{'measurements': [{'value': '0.08639', 'groupId': 'OG000', 'lowerLimit': '-0.01650', 'upperLimit': '0.1893'}, {'value': '0.05948', 'groupId': 'OG001', 'lowerLimit': '-0.02453', 'upperLimit': '0.1435'}]}]}, {'title': 'AZD7594 250 µg vs.PBO', 'categories': [{'measurements': [{'value': '0.1355', 'groupId': 'OG000', 'lowerLimit': '0.03283', 'upperLimit': '0.2382'}, {'value': '0.05948', 'groupId': 'OG001', 'lowerLimit': '-0.02453', 'upperLimit': '0.1435'}]}]}, {'title': 'AZD7594 800 µg vs.PBO', 'categories': [{'measurements': [{'value': '0.2072', 'groupId': 'OG000', 'lowerLimit': '0.1041', 'upperLimit': '0.3104'}, {'value': '0.05948', 'groupId': 'OG001', 'lowerLimit': '-0.02453', 'upperLimit': '0.1435'}]}]}], 'analyses': [{'pValue': '0.6379', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 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Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '7.475', 'groupId': 'OG000', 'lowerLimit': '-4.426', 'upperLimit': '19.38'}, {'value': '-8.257', 'groupId': 'OG001', 'lowerLimit': '-18.71', 'upperLimit': '2.193'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '6.040', 'groupId': 'OG000', 'lowerLimit': '-5.839', 'upperLimit': '17.92'}, {'value': '-8.257', 'groupId': 'OG001', 'lowerLimit': '-18.71', 'upperLimit': '2.193'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '11.65', 'groupId': 'OG000', 'lowerLimit': '-0.2692', 'upperLimit': '23.58'}, {'value': '-8.257', 'groupId': 'OG001', 'lowerLimit': '-18.71', 'upperLimit': '2.193'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.73', 'ciLowerLimit': '5.039', 'ciUpperLimit': '26.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.384', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.30', 'ciLowerLimit': '3.534', 'ciUpperLimit': '25.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.419', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.91', 'ciLowerLimit': '9.068', 'ciUpperLimit': '30.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.459', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Every evening from Day 1 to Day 14 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in evening peak expiratory flow (ePEF) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as ePEF together with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).', 'unitOfMeasure': 'L/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.6776', 'groupId': 'OG000', 'lowerLimit': '-1.071', 'upperLimit': '-0.2841'}, {'value': '-0.3340', 'groupId': 'OG001', 'lowerLimit': '-0.6733', 'upperLimit': '0.005227'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.8193', 'groupId': 'OG000', 'lowerLimit': '-1.212', 'upperLimit': '-0.4267'}, {'value': '-0.3340', 'groupId': 'OG001', 'lowerLimit': '-0.6733', 'upperLimit': '0.005227'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '-1.137', 'groupId': 'OG000', 'lowerLimit': '-1.531', 'upperLimit': '-0.7422'}, {'value': '-0.3340', 'groupId': 'OG001', 'lowerLimit': '-0.6733', 'upperLimit': '0.005227'}]}]}], 'analyses': [{'pValue': '0.0723', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3435', 'ciLowerLimit': '-0.7189', 'ciUpperLimit': '0.03179', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1890', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4852', 'ciLowerLimit': '-0.8631', 'ciUpperLimit': '-0.1073', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1903', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8026', 'ciLowerLimit': '-1.183', 'ciUpperLimit': '-0.4224', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1914', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Every day from Day 1 to Day 15 (from evening of Day 1 to morning of Day 15)', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in average daily use of salbutamol (each morning and evening) in each treatment period.', 'unitOfMeasure': 'Number of inhalations per day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.2929', 'groupId': 'OG000', 'lowerLimit': '-0.4744', 'upperLimit': '-0.1113'}, {'value': '0.01428', 'groupId': 'OG001', 'lowerLimit': '-0.1281', 'upperLimit': '0.1567'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.1681', 'groupId': 'OG000', 'lowerLimit': '-0.3496', 'upperLimit': '0.01335'}, {'value': '0.1428', 'groupId': 'OG001', 'lowerLimit': '-0.1281', 'upperLimit': '0.1567'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.4158', 'groupId': 'OG000', 'lowerLimit': '-0.5975', 'upperLimit': '-0.2342'}, {'value': '0.01428', 'groupId': 'OG001', 'lowerLimit': '-0.1281', 'upperLimit': '0.1567'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3071', 'ciLowerLimit': '-0.5159', 'ciUpperLimit': '-0.09836', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1051', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0883', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1824', 'ciLowerLimit': '-0.3927', 'ciUpperLimit': '0.02789', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1059', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4301', 'ciLowerLimit': '-0.6397', 'ciUpperLimit': '-0.2205', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1055', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and on Day 15 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a higher score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.2724', 'groupId': 'OG000', 'lowerLimit': '-0.4309', 'upperLimit': '-0.1138'}, {'value': '-0.1072', 'groupId': 'OG001', 'lowerLimit': '-0.2320', 'upperLimit': '0.01748'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.1980', 'groupId': 'OG000', 'lowerLimit': '-0.3565', 'upperLimit': '-0.03952'}, {'value': '-0.1072', 'groupId': 'OG001', 'lowerLimit': '-0.2320', 'upperLimit': '0.01748'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.3604', 'groupId': 'OG000', 'lowerLimit': '-0.5191', 'upperLimit': '-0.2017'}, {'value': '-0.1072', 'groupId': 'OG001', 'lowerLimit': '-0.2320', 'upperLimit': '0.01748'}]}]}], 'analyses': [{'pValue': '0.0741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1651', 'ciLowerLimit': '-0.3466', 'ciUpperLimit': '0.01638', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09139', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3265', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09079', 'ciLowerLimit': '-0.2736', 'ciUpperLimit': '0.09201', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09204', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2532', 'ciLowerLimit': '-0.4354', 'ciUpperLimit': '-0.07092', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09176', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and on Day 8 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a lower score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of Night-time Awakenings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.4120', 'groupId': 'OG000', 'lowerLimit': '-0.7229', 'upperLimit': '-0.1010'}, {'value': '0.006541', 'groupId': 'OG001', 'lowerLimit': '-0.2509', 'upperLimit': '0.2640'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.1729', 'groupId': 'OG000', 'lowerLimit': '-0.4833', 'upperLimit': '0.1376'}, {'value': '0.006541', 'groupId': 'OG001', 'lowerLimit': '-0.2509', 'upperLimit': '0.2640'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.7595', 'groupId': 'OG000', 'lowerLimit': '-1.071', 'upperLimit': '-0.4479'}, {'value': '0.006541', 'groupId': 'OG001', 'lowerLimit': '-0.2509', 'upperLimit': '0.2640'}]}]}], 'analyses': [{'pValue': '0.0116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4185', 'ciLowerLimit': '-0.7414', 'ciUpperLimit': '-0.09563', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1626', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2732', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1794', 'ciLowerLimit': '-0.5027', 'ciUpperLimit': '0.1438', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1628', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7661', 'ciLowerLimit': '-1.091', 'ciUpperLimit': '-0.4411', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1636', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and from Day 2 to Day 15 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change in nighttime awakenings in each treatment period. The patients were asked to answer \'Yes\' or \'No\' to the question of "Did your asthma cause you to wake up last night?". If yes, the number and percentage of days that had a night-time awakening were determined for each of the study periods.', 'unitOfMeasure': 'Number of nighttime awakenings', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of Daily Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.1190', 'groupId': 'OG000', 'lowerLimit': '-0.2190', 'upperLimit': '-0.01903'}, {'value': '-0.01229', 'groupId': 'OG001', 'lowerLimit': '-0.09729', 'upperLimit': '0.07270'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.09435', 'groupId': 'OG000', 'lowerLimit': '-0.1941', 'upperLimit': '0.005411'}, {'value': '-0.01229', 'groupId': 'OG001', 'lowerLimit': '-0.09729', 'upperLimit': '0.07270'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '-0.2150', 'groupId': 'OG000', 'lowerLimit': '-0.3151', 'upperLimit': '-0.1149'}, {'value': '-0.01229', 'groupId': 'OG001', 'lowerLimit': '-0.09729', 'upperLimit': '0.07270'}]}]}], 'analyses': [{'pValue': '0.0349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1067', 'ciLowerLimit': '-0.2057', 'ciUpperLimit': '-0.007755', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04982', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08205', 'ciLowerLimit': '-0.1817', 'ciUpperLimit': '0.01756', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05015', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2027', 'ciLowerLimit': '-0.3028', 'ciUpperLimit': '-0.1025', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05044', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and from Day 1 to Day 14 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change in daily symptom score from baseline to average of treatment period post dose (Day 1-14) in each treatment period. Severity scores for asthma symptoms were recorded twice daily, once in the morning and once in the evening with the scoring system of 0-no asthma symptoms, 1-toleratable asthma symptoms, 2-discomfort asthma symptoms with normal activities (or with sleep) and 3-asthma symptoms with impaired normal activities (or to sleep).', 'unitOfMeasure': 'Unit on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Efficacy of AZD7594 by Assessment of Asthma Control Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594', 'description': 'AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}], 'classes': [{'title': 'AZD7594 58 μg vs. PBO', 'categories': [{'measurements': [{'value': '0.9502', 'groupId': 'OG000', 'lowerLimit': '0.3166', 'upperLimit': '1.584'}, {'value': '0.2773', 'groupId': 'OG001', 'lowerLimit': '-0.2745', 'upperLimit': '0.8290'}]}]}, {'title': 'AZD7594 250 μg vs. PBO', 'categories': [{'measurements': [{'value': '0.705', 'groupId': 'OG000', 'lowerLimit': '0.07299', 'upperLimit': '1.338'}, {'value': '0.2773', 'groupId': 'OG001', 'lowerLimit': '-0.2745', 'upperLimit': '0.8290'}]}]}, {'title': 'AZD7594 800 μg vs. PBO', 'categories': [{'measurements': [{'value': '1.219', 'groupId': 'OG000', 'lowerLimit': '0.5843', 'upperLimit': '1.853'}, {'value': '0.2773', 'groupId': 'OG001', 'lowerLimit': '-0.2745', 'upperLimit': '0.8290'}]}]}], 'analyses': [{'pValue': '0.0247', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6730', 'ciLowerLimit': '0.08779', 'ciUpperLimit': '1.258', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2946', 'groupDescription': 'AZD7594 58 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1521', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4281', 'ciLowerLimit': '-0.1607', 'ciUpperLimit': '1.017', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2965', 'groupDescription': 'AZD7594 250 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9415', 'ciLowerLimit': '0.3483', 'ciUpperLimit': '1.535', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2987', 'groupDescription': 'AZD7594 800 μg vs. PBO', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and from Day 1 to Day 14 post-dose in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of amount of asthma control days in each treatment period. An asthma control day was defined as a day with asthma symptom score = 0, a night with no awakenings due to asthma symptoms and a day with no use of rescue medication. A given calendar day was defined as an asthma control day if it fulfills the criteria for a symptom-free day and for a rescue medication-free day', 'unitOfMeasure': 'Asthma control days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for AZD7594 DPI once daily'}, {'id': 'OG001', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG002', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG003', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'AE causally related to IP', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any AE with an outcome of death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any SAE (including events with outcome of death)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any AE leading to discontinuation of IP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Screening to Follow-up (these two examinations are up to 165 days apart)', 'description': 'Assessment of safety and tolerability of three dose levels of AZD7594 in participants with mild to moderate asthma. IP referred to investigational product.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAF) included all randomized participants who received at least one dose of randomized study drug during the treatment periods of the study. This analysis set was classified by actual treatment received. If no participants received incorrect treatment then the SAF was identical to the FAS.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '36.40', 'spread': '32.80', 'groupId': 'OG000'}, {'value': '92.02', 'spread': '34.17', 'groupId': 'OG001'}, {'value': '169.7', 'spread': '43.21', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'description': 'Comparison of Cmax (maximum observed plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set (PKS) included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '85.02', 'spread': '8.21', 'groupId': 'OG000'}, {'value': '188.4', 'spread': '30.58', 'groupId': 'OG001'}, {'value': '371.1', 'spread': '31.55', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'description': 'Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset of all randomized participants; 24-hour PK sampling was performed on Day 14, the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '54.97', 'spread': '19.70', 'groupId': 'OG000'}, {'value': '158.7', 'spread': '35.01', 'groupId': 'OG001'}, {'value': '421.6', 'spread': '37.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Ratio Estimate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '272.20', 'ciLowerLimit': '237.43', 'ciUpperLimit': '312.05', 'groupDescription': 'AZD7594 250 μg versus AZD7594 58 μg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Ratio Estimate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '676.13', 'ciLowerLimit': '580.91', 'ciUpperLimit': '786.95', 'groupDescription': 'AZD7594 800 μg versus AZD7594 58 μg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '467.1', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '1725', 'spread': '44.33', 'groupId': 'OG001'}, {'value': '4894', 'spread': '52.48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Ratio Estimate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '337.82', 'ciLowerLimit': '290.80', 'ciUpperLimit': '392.43', 'groupDescription': 'AZD7594 250 μg versus AZD7594 58 μg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Ratio Estimate (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '964.62', 'ciLowerLimit': '816.13', 'ciUpperLimit': '1140.13', 'groupDescription': 'AZD7594 800 μg versus AZD7594 58 μg', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '56.85', 'spread': '45.40', 'groupId': 'OG000'}, {'value': '188.5', 'spread': '30.57', 'groupId': 'OG001'}, {'value': '371.8', 'spread': '31.63', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '467.3', 'spread': '17.93', 'groupId': 'OG000'}, {'value': '1728', 'spread': '44.36', 'groupId': 'OG001'}, {'value': '4897', 'spread': '52.48', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 and Day 14 in each period (in participants with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (Day 1 and Day 14)) of AZD7594 (i.e. in participants with intensive pharmacokinetic assessments)', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.27'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.50'}, {'value': '0.25', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'description': 'Comparison of tmax (time to reach maximum plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '0.50'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '0.27'}, {'value': '0.25', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'unitOfMeasure': 'Hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '19.48', 'spread': '17.93', 'groupId': 'OG000'}, {'value': '71.89', 'spread': '44.33', 'groupId': 'OG001'}, {'value': '203.9', 'spread': '52.55', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '380.8', 'spread': '32.80', 'groupId': 'OG000'}, {'value': '223.4', 'spread': '34.17', 'groupId': 'OG001'}, {'value': '128.5', 'spread': '43.21', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 in each period', 'description': 'Comparison of Cmax/D (dose-normalized Cmax) of AZD7594', 'unitOfMeasure': 'pmol/L/μmol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '4886', 'spread': '17.91', 'groupId': 'OG000', 'lowerLimit': '3977', 'upperLimit': '4944'}, {'value': '4188', 'spread': '44.33', 'groupId': 'OG001'}, {'value': '3708', 'spread': '52.48', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 14 in each period', 'description': 'Comparison of AUC(0-24)/D (dose-normalized AUC(0-24)) of AZD7594', 'unitOfMeasure': 'h*pmol/L/ μmol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.'}, {'type': 'SECONDARY', 'title': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD7594 58 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 29 μg'}, {'id': 'OG001', 'title': 'AZD7594 250 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 125 μg'}, {'id': 'OG002', 'title': 'AZD7594 800 μg', 'description': 'AZD7594 DPI once daily - 2 capsules of 400 μg'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not applicable for AZD7594 58 μg. Will be reported in the separate population PK report', 'groupId': 'OG000'}, {'value': '55.95', 'spread': '51.74', 'groupId': 'OG001'}, {'value': '191.6', 'spread': '68.27', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 14 at pre-dose in each period', 'description': 'Comparison of steady-state minimum (pre-dose) concentration (Cmin) of AZD7594 in each treatment period', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The subset of all randomized participants, 24-hour PK sampling was performed on Day 14, primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data. Cmin was not determined for AZD7594 58 μg'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)', 'description': 'Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG001', 'title': 'Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)', 'description': 'Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG002', 'title': 'Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)', 'description': 'Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG003', 'title': 'Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)', 'description': 'Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG004', 'title': 'Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)', 'description': 'Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG005', 'title': 'Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)', 'description': 'Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG006', 'title': 'Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)', 'description': 'Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG007', 'title': 'Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)', 'description': 'Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'FG008', 'title': 'Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)', 'description': 'Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Study-specific withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Randomization to wrong PK sampling group', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted in Germany (9 centers) and Bulgaria (1 center). A total of 54 participants with mild to moderate asthma were randomized after screening, and received study treatment (AZD7594 or placebo) given over 3 Treatment Periods in an incomplete block crossover design.', 'preAssignmentDetails': 'The study consisted of a 2-part run-in period, 3 treatment periods separated by intervening wash-out periods, and a final period of safety follow-up .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '54', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1 (Placebo + AZD7594 58 μg + AZD7594 250 μg)', 'description': 'Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg treatment in Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG001', 'title': 'Sequence 2 (Placebo + AZD7594 250 μg + AZD7594 800 μg)', 'description': 'Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG002', 'title': 'Sequence 3 (Placebo + AZD7594 800 µg + AZD7594 58 µg)', 'description': 'Participants received Placebo in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG003', 'title': 'Sequence 4 (AZD7594 58 μg + Placebo + AZD7594 800 μg)', 'description': 'Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 800 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG004', 'title': 'Sequence 5 (AZD7594 58 µg + AZD7594 800 µg + Placebo)', 'description': 'Participants received AZD7594 58 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 800 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG005', 'title': 'Sequence 6 (AZD7594 250 μg + Placebo + AZD7594 58 μg)', 'description': 'Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 58 μg in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG006', 'title': 'Sequence 7 (AZD7594 250 μg + AZD7594 58 μg + Placebo)', 'description': 'Participants received AZD7594 250 μg in Treatment Period 1 (1st intervention - 14 days), AZD7594 58 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention- 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG007', 'title': 'Sequence 8 (AZD7594 800 μg + Placebo + AZD7594 250 μg)', 'description': 'Participants received AZD7594 800 μg in Treatment Period 1 (1st intervention - 14 days), Placebo in Treatment Period 2 (2nd intervention - 14 days) and AZD7594 250 μg Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG008', 'title': 'Sequence 9 (AZD7594 800 μg + AZD7594 250 μg + Placebo)', 'description': 'Participant received AZD7594 800 μg in Treatment Period 1 (1st intervention 14 days), AZD7594 250 μg in Treatment Period 2 (2nd intervention - 14 days) and Placebo in Treatment Period 3 (3rd intervention - 14 days). After treatment periods 1 and 2, participants had an intervening wash-out period of 21 days.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age (years)', 'categories': [{'measurements': [{'value': '49', 'spread': '14', 'groupId': 'BG000'}, {'value': '50', 'spread': '10', 'groupId': 'BG001'}, {'value': '56', 'spread': '10', 'groupId': 'BG002'}, {'value': '50', 'spread': '17', 'groupId': 'BG003'}, {'value': '49', 'spread': '7', 'groupId': 'BG004'}, {'value': '55', 'spread': '9', 'groupId': 'BG005'}, {'value': '48', 'spread': '14', 'groupId': 'BG006'}, {'value': '55', 'spread': '14', 'groupId': 'BG007'}, {'value': '46', 'spread': '13', 'groupId': 'BG008'}, {'value': '51', 'spread': '12', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '44', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2015-06-17', 'resultsFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-10', 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15', 'timeFrame': 'On Day 1 (pre-dose) and on Day 15 in each period', 'description': 'Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product \\[IMP\\] on Day 14) with placebo'}], 'secondaryOutcomes': [{'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8', 'timeFrame': 'On Day 1 (pre-dose) and on Day 8 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 8'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15', 'timeFrame': 'On Day 1 (pre-dose) and on Day 15 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 15'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8', 'timeFrame': 'On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product \\[IMP\\] on Day 7)'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15', 'timeFrame': 'On Day 1 (pre-dose) and on Day 15 (pre-dose) in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product \\[IMP\\] on Day 14)'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8', 'timeFrame': 'On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product \\[IMP\\] on Day 7)'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Peak Expiratory Flow (mPEF) Before Administration Over the Treatment Period', 'timeFrame': 'Every morning at pre-dose from Day 1 to Day 15', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in morning peak expiratory flow (mPEF) before administration of the investigational medicinal product (IMP) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as mPEF with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period', 'timeFrame': 'Every evening from Day 1 to Day 14 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in evening peak expiratory flow (ePEF) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as ePEF together with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period', 'timeFrame': 'Every day from Day 1 to Day 15 (from evening of Day 1 to morning of Day 15)', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline in average daily use of salbutamol (each morning and evening) in each treatment period.'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5', 'timeFrame': 'At baseline and on Day 15 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a higher score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.'}, {'measure': 'Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5', 'timeFrame': 'At baseline and on Day 8 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a lower score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.'}, {'measure': 'Efficacy of AZD7594 by Assessment of Night-time Awakenings', 'timeFrame': 'At baseline and from Day 2 to Day 15 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change in nighttime awakenings in each treatment period. The patients were asked to answer \'Yes\' or \'No\' to the question of "Did your asthma cause you to wake up last night?". If yes, the number and percentage of days that had a night-time awakening were determined for each of the study periods.'}, {'measure': 'Efficacy of AZD7594 by Assessment of Daily Symptom Score', 'timeFrame': 'At baseline and from Day 1 to Day 14 in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of change in daily symptom score from baseline to average of treatment period post dose (Day 1-14) in each treatment period. Severity scores for asthma symptoms were recorded twice daily, once in the morning and once in the evening with the scoring system of 0-no asthma symptoms, 1-toleratable asthma symptoms, 2-discomfort asthma symptoms with normal activities (or with sleep) and 3-asthma symptoms with impaired normal activities (or to sleep).'}, {'measure': 'Efficacy of AZD7594 by Assessment of Asthma Control Days', 'timeFrame': 'At baseline and from Day 1 to Day 14 post-dose in each period', 'description': 'The efficacy of AZD7594 was assessed in terms of amount of asthma control days in each treatment period. An asthma control day was defined as a day with asthma symptom score = 0, a night with no awakenings due to asthma symptoms and a day with no use of rescue medication. A given calendar day was defined as an asthma control day if it fulfills the criteria for a symptom-free day and for a rescue medication-free day'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From Screening to Follow-up (these two examinations are up to 165 days apart)', 'description': 'Assessment of safety and tolerability of three dose levels of AZD7594 in participants with mild to moderate asthma. IP referred to investigational product.'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594', 'timeFrame': 'On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'description': 'Comparison of Cmax (maximum observed plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594', 'timeFrame': 'On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'description': 'Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594', 'timeFrame': 'On Day 1 and Day 14 in each period (in participants with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (Day 1 and Day 14)) of AZD7594 (i.e. in participants with intensive pharmacokinetic assessments)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594', 'timeFrame': 'On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)', 'description': 'Comparison of tmax (time to reach maximum plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594', 'timeFrame': 'On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)', 'description': 'Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594', 'timeFrame': 'On Day 1 in each period', 'description': 'Comparison of Cmax/D (dose-normalized Cmax) of AZD7594'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594', 'timeFrame': 'On Day 14 in each period', 'description': 'Comparison of AUC(0-24)/D (dose-normalized AUC(0-24)) of AZD7594'}, {'measure': 'Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594', 'timeFrame': 'On Day 14 at pre-dose in each period', 'description': 'Comparison of steady-state minimum (pre-dose) concentration (Cmin) of AZD7594 in each treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mild to moderate asthma', 'FEV1', 'efficacy', 'safety'], 'conditions': ['Asthma', 'Efficacy', 'Safety']}, 'referencesModule': {'references': [{'pmid': '30777086', 'type': 'DERIVED', 'citation': 'Brown MN, Fuhr R, Beier J, Su HL, Chen Y, Forsman H, Hamren UW, Jackson H, Aggarwal A. Efficacy and safety of AZD7594, an inhaled non-steroidal selective glucocorticoid receptor modulator, in patients with asthma: a phase 2a randomized, double blind, placebo-controlled crossover trial. Respir Res. 2019 Feb 18;20(1):37. doi: 10.1186/s12931-019-1000-7.'}]}, 'descriptionModule': {'briefSummary': 'This study will be a randomised, double-blind, multiple dose (14 days), placebo-controlled, multi-center study to assess efficacy and safety of three dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.', 'detailedDescription': 'This is a randomized, double-blind, multiple dosing (14 ± 1 days), placebo-controlled, incomplete block crossover, multi-center study to assess efficacy and safety of 3 dose levels of AZD7594, given once daily by inhalation, in patients with mild to moderate asthma.\n\nThis multi-center study will be conducted at multiple sites in Europe. It is planned that approximately 48 patients with mild to moderate asthma will be randomized into the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index of 18 to 35 kg/m2\n* Men and women 18 to 75 years of age, inclusive\n* Patients need to be non-smokers or ex-smokers (quit ≥ 6 months before the Visit 1) with total smoking history of \\< 10 pack years\n* Documented clinical diagnosis of asthma for ≥ 6 months before the Visit 1\n* Patients on low-dose inhaled corticosteroids (ICS) (equivalent of budesonide ≤ 400 μg per day) or low-dose ICS/long-acting β-2 agonist (LABA), or not on any inhaled steroids, or patients on montelukast\n* Patients should be controlled on low dose budesonide during the first 14 ±2 days of Run-in Part 1, i.e., they need to have ACQ-5 of ≤ 1.5 at Visit 2.\n* Prebronchodilator FEV1 at Visit 3 should be between 40% and 90% of predicted (mean of 2 predose measurements taken 30 minutes apart).\n* All patients need to have FeNO concentrations of ≥ 25 parts per billion at Visit 3\n* Demonstrate the ability to use the study inhalation device properly\n* Women must be of nonchildbearing potential defined as meeting 1 of the following criteria:\n\n * Permanently or surgically sterilized, including hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy\n * Postmenopausal; aged ≤ 50 years and have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range\n * Postmenopausal; aged \\> 50 years and have been amenorrheic for 12 months or more, following cessation of all exogenous hormonal treatments\n* Male patients should be willing to use a condom to prevent pregnancy and exposure of a female partner to AZD7594 and should refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to the IMPs or excipients, including lactose\n* Systemic steroid use in the 6 weeks before Visit 1\n* Any active disease other than asthma\n* Patients on medium to high-dose ICS (equivalent of budesonide \\> 400 μg per day) or on inhaled anticholinergic combination within the 6 weeks prior to Visit 1\n* Compliance with the eDiary of at least 80% of the days is expected in both Run-in and Treatment Periods. Patients with \\< 80% eDiary compliance during Run-in Periods would not be randomized\n* Treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab within 6 months or 5 half-lives before Visit 1, whichever is longer\n* History or clinical suspicion of any clinically relevant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study, or any other safety concerns in the opinion of the Investigator\n* ACQ-5 ≥ 3 at any time between Visits 1 and 3\n* Any contraindication against the use of vagolytic or sympathomimetic drugs as judged by the Investigator.\n* Patients with hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)\n* Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1\n* Pregnant woman or a nursing mother\n* Suspicion of Gilbert's syndrome\n* Vulnerable persons (e.g., persons kept in detention)\n* ACQ-5 of ≥ 3 or daily rescue use of ≥ 12 puffs for ≥ 3 consecutive days during the enrollment period\n* Hypersensitivity to the active substance or to any of the excipients of the Run-in medication (i.e., budesonide)"}, 'identificationModule': {'nctId': 'NCT02479412', 'briefTitle': 'A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A RANDOMIZED, DOUBLE BLIND, MULTIPLE DOSING (14 DAYS), PLACEBO-CONTROLLED, INCOMPLETE BLOCK CROSSOVER, MULTI CENTER STUDY TO ASSESS EFFICACY AND SAFETY OF THREE DOSE LEVELS OF AZD7594, GIVEN ONCE DAILY BY INHALATION, IN PATIENTS WITH MILD TO MODERATE ASTHMA', 'orgStudyIdInfo': {'id': 'D3741C00003'}, 'secondaryIdInfos': [{'id': '2014-005306-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Placebo once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3', 'interventionNames': ['Drug: 250 µg AZD7594 once daily', 'Drug: 58 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Placebo once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3', 'interventionNames': ['Drug: 800 μg AZD7594 once daily', 'Drug: 250 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'Placebo once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3', 'interventionNames': ['Drug: 800 μg AZD7594 once daily', 'Drug: 58 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': '58 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 800 µg AZD7594 once daily for 14 days in Period 3', 'interventionNames': ['Drug: 800 μg AZD7594 once daily', 'Drug: 58 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': '250 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 58 µg AZD7594 once daily for 14 days in Period 3', 'interventionNames': ['Drug: 250 µg AZD7594 once daily', 'Drug: 58 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 8', 'description': '800 µg AZD7594 once daily for 14 days in Period 1, Placebo once daily for 14 days in Period 2 and 250 µg AZD7594 once daily for 14 days in Period 3', 'interventionNames': ['Drug: 800 μg AZD7594 once daily', 'Drug: 250 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': '58 µg AZD7594 once daily for 14 days in Period 1, 800 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3', 'interventionNames': ['Drug: 800 μg AZD7594 once daily', 'Drug: 58 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 7', 'description': '250 µg AZD7594 once daily for 14 days in Period 1, 58 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3', 'interventionNames': ['Drug: 250 µg AZD7594 once daily', 'Drug: 58 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 9', 'description': '800 µg AZD7594 once daily for 14 days in Period 1, 250 µg AZD7594 once daily for 14 days in Period 2 and Placebo once daily for 14 days in Period 3', 'interventionNames': ['Drug: 800 μg AZD7594 once daily', 'Drug: 250 µg AZD7594 once daily', 'Drug: Placebo once daily', 'Drug: Salbutamol']}], 'interventions': [{'name': '800 μg AZD7594 once daily', 'type': 'DRUG', 'otherNames': ['High dose of AZD7594'], 'description': 'Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule', 'armGroupLabels': ['Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 8', 'Sequence 9']}, {'name': '250 µg AZD7594 once daily', 'type': 'DRUG', 'otherNames': ['Medium dose of AZD7594'], 'description': 'Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 6', 'Sequence 7', 'Sequence 8', 'Sequence 9']}, {'name': '58 µg AZD7594 once daily', 'type': 'DRUG', 'otherNames': ['Low dose of AZD7594'], 'description': 'Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule', 'armGroupLabels': ['Sequence 1', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6', 'Sequence 7']}, {'name': 'Placebo once daily', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6', 'Sequence 7', 'Sequence 8', 'Sequence 9']}, {'name': 'Salbutamol', 'type': 'DRUG', 'otherNames': ['Rescue medication'], 'description': 'Inhalation as needed', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6', 'Sequence 7', 'Sequence 8', 'Sequence 9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '10717', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10969', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '20354', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22143', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '23552', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '65187', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Rainard Fuhr, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PAREXEL International GmbH, Berlin, Germany'}, {'name': 'Ulrike Westerhausen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pneumologisches Studienzentrum, Berlin, Germany'}, {'name': 'Oliver Kornmann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IKF Pneumologie GmbH, Frankfurt, Germany'}, {'name': 'Jutta Beier, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insaf GmbH, Wiesbaden, Germany'}, {'name': 'Christine Grigat, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Hamburg GmbH, Hamburg, Germany'}, {'name': 'Andrea Ludwig-Sengpiel, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KLB Gesundheitsforschung Lübeck GmbH, Lübeck, Germany'}, {'name': 'Dirk Skowasch, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Bonn, Department of Internal Medicine II, Bonn, Germany'}, {'name': 'Anne-Marie Kirsten, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pneumologisches Forschungsinstitut an der LungenClinic Großhansdorf, Großhansdorf, Germany'}, {'name': 'Tanya Kralimarkova, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'COMAC Medical Ltd., Sofia, Bulgaria'}, {'name': 'Anneliese Linnhoff, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Praxis für Lungen- und Bronchialheilkunde, Allergologie und Umweltmedizin'}, {'name': 'Margret Jandl, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamburger Institut für Therapie Forschung GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}