Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-01 @ 6:21 PM
Study NCT ID:
NCT01197794
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2010-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Sponsor:
Organization:
Raw JSON
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'seriousNumAtRisk': 164, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily', 'otherNumAtRisk': 164, 'otherNumAffected': 21, 'seriousNumAtRisk': 164, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily', 'otherNumAtRisk': 163, 'otherNumAffected': 20, 'seriousNumAtRisk': 163, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily', 'otherNumAtRisk': 163, 'otherNumAffected': 32, 'seriousNumAtRisk': 163, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 163, 'otherNumAffected': 21, 'seriousNumAtRisk': 163, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 7}, 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164, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre-bronchodilator FEV1 at the Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}, {'value': '158', 'groupId': 'OG004'}, {'value': '157', 'groupId': 'OG005'}, {'value': '154', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.21'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '0.25'}, {'value': '0.19', 'groupId': 'OG002', 'lowerLimit': '0.13', 'upperLimit': '0.24'}, {'value': '0.15', 'groupId': 'OG003', 'lowerLimit': '0.10', 'upperLimit': '0.21'}, {'value': 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Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. 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The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '163', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}, {'value': '163', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Twelve week treatment period', 'description': 'Number of participants who had at least one adverse event during the randomized treatment period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study medication and from whom any data after randomization was available', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Severe Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}, {'value': '161', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Twelve week treatment period', 'description': 'Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}, {'value': '161', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Twelve week treatment period', 'description': 'Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Well-controlled Asthma (ACQ5<=0.75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}, {'value': '161', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Twelve week treatment period', 'description': 'The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5\\<=0.75 at the end of the 12-week treatment period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Asthma Quality of Life Questionnaire (AQLQ(S))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}, {'value': '155', 'groupId': 'OG004'}, {'value': '152', 'groupId': 'OG005'}, {'value': '148', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'groupId': 'OG000', 'lowerLimit': '0.60', 'upperLimit': '0.85'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '0.86'}, {'value': '0.75', 'groupId': 'OG002', 'lowerLimit': '0.63', 'upperLimit': '0.87'}, {'value': '0.80', 'groupId': 'OG003', 'lowerLimit': '0.68', 'upperLimit': '0.92'}, {'value': '0.82', 'groupId': 'OG004', 'lowerLimit': '0.69', 'upperLimit': '0.94'}, {'value': '0.72', 'groupId': 'OG005', 'lowerLimit': '0.59', 'upperLimit': '0.84'}, {'value': '0.65', 'groupId': 'OG006', 'lowerLimit': '0.53', 'upperLimit': '0.78'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Twelve week treatment period', 'description': 'The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.', 'unitOfMeasure': 'Score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}, {'value': '160', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '-0.18'}, {'value': '-0.26', 'groupId': 'OG001', 'lowerLimit': '-0.38', 'upperLimit': '-0.14'}, {'value': '-0.28', 'groupId': 'OG002', 'lowerLimit': '-0.40', 'upperLimit': '-0.16'}, {'value': '-0.33', 'groupId': 'OG003', 'lowerLimit': '-0.45', 'upperLimit': '-0.21'}, {'value': '-0.34', 'groupId': 'OG004', 'lowerLimit': '-0.46', 'upperLimit': '-0.22'}, {'value': '-0.30', 'groupId': 'OG005', 'lowerLimit': '-0.42', 'upperLimit': '-0.17'}, {'value': '-0.27', 'groupId': 'OG006', 'lowerLimit': '-0.39', 'upperLimit': '-0.15'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Twelve week treatment period', 'description': 'Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.', 'unitOfMeasure': 'Score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}, {'type': 'SECONDARY', 'title': 'Total Reliever Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '162', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}, {'value': '160', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'OG001', 'title': 'Arm 2 - AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'OG002', 'title': 'Arm 3 - AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'OG003', 'title': 'Arm 4 - AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'OG004', 'title': 'Arm 5 - AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'OG005', 'title': 'Arm 6 - AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'OG006', 'title': 'Arm7-Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'groupId': 'OG000', 'lowerLimit': '-0.72', 'upperLimit': '-0.31'}, {'value': '-0.22', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '-0.01'}, {'value': '-0.38', 'groupId': 'OG002', 'lowerLimit': '-0.58', 'upperLimit': '-0.17'}, {'value': '-0.39', 'groupId': 'OG003', 'lowerLimit': '-0.59', 'upperLimit': '-0.18'}, {'value': '-0.37', 'groupId': 'OG004', 'lowerLimit': '-0.58', 'upperLimit': '-0.17'}, {'value': '-0.37', 'groupId': 'OG005', 'lowerLimit': '-0.58', 'upperLimit': '-0.17'}, {'value': '-0.35', 'groupId': 'OG006', 'lowerLimit': '-0.56', 'upperLimit': '-0.15'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Twelve week treatment period', 'description': 'Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.', 'unitOfMeasure': 'Number of inhalations', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint', 'anticipatedPostingDate': '2013-02'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'FG001', 'title': 'AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'FG002', 'title': 'AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'FG003', 'title': 'AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'FG004', 'title': 'AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'FG005', 'title': 'AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'FG006', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'comment': 'Two participants did not receive study treatment', 'groupId': 'FG001', 'numSubjects': '161'}, {'comment': 'Two participants did not receive study treatment', 'groupId': 'FG002', 'numSubjects': '166'}, {'groupId': 'FG003', 'numSubjects': '164'}, {'comment': 'One participant excluded due to Good Clinical Practice (GCP) violation at centre 4323', 'groupId': 'FG004', 'numSubjects': '163'}, {'groupId': 'FG005', 'numSubjects': '163'}, {'comment': 'Two participants excluded due to Good Clinical Practice (GCP) violation at centre 4323', 'groupId': 'FG006', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '153'}, {'groupId': 'FG003', 'numSubjects': '152'}, {'groupId': 'FG004', 'numSubjects': '149'}, {'groupId': 'FG005', 'numSubjects': '144'}, {'groupId': 'FG006', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Development of study withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}]}]}], 'recruitmentDetails': '1144 participants were randomized. The first participant was enrolled on 19 October 2010 and the last participant completed the study on 16 February 2012.', 'preAssignmentDetails': 'Participants were screened for a period of 31 days out of which 17 days for enrollment and 2 weeks for run-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}, {'value': '163', 'groupId': 'BG005'}, {'value': '161', 'groupId': 'BG006'}, {'value': '1141', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD1981 400 mg', 'description': 'AZD1981 400 mg twice daily'}, {'id': 'BG001', 'title': 'AZD1981 200 mg', 'description': 'AZD1981 200 mg once daily'}, {'id': 'BG002', 'title': 'AZD1981 100 mg', 'description': 'AZD1981 100 mg twice daily'}, {'id': 'BG003', 'title': 'AZD1981 80 mg', 'description': 'AZD1981 80 mg once daily'}, {'id': 'BG004', 'title': 'AZD1981 40 mg', 'description': 'AZD1981 40 mg twice daily'}, {'id': 'BG005', 'title': 'AZD1981 10 mg', 'description': 'AZD1981 10 mg twice daily'}, {'id': 'BG006', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '13.98', 'groupId': 'BG000'}, {'value': '46.7', 'spread': '12.84', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '14.65', 'groupId': 'BG002'}, {'value': '45.4', 'spread': '13.22', 'groupId': 'BG003'}, {'value': '46.3', 'spread': '13.15', 'groupId': 'BG004'}, {'value': '44.5', 'spread': '13.76', 'groupId': 'BG005'}, {'value': '45.7', 'spread': '13.50', 'groupId': 'BG006'}, {'value': '45.9', 'spread': '13.58', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '76', 'groupId': 'BG006'}, {'value': '561', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}, {'value': '580', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}, {'value': '113', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}, {'value': '824', 'groupId': 'BG007'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '195', 'groupId': 'BG007'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '94', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Time since asthma diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '13.87', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '14.25', 'groupId': 'BG001'}, {'value': '18.6', 'spread': '14.74', 'groupId': 'BG002'}, {'value': '18.3', 'spread': '13.04', 'groupId': 'BG003'}, {'value': '18.0', 'spread': '14.35', 'groupId': 'BG004'}, {'value': '17.3', 'spread': '12.40', 'groupId': 'BG005'}, {'value': '17.5', 'spread': '13.27', 'groupId': 'BG006'}, {'value': '18.1', 'spread': '13.70', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking status', 'classes': [{'title': 'Former smoker', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '144', 'groupId': 'BG007'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}, {'value': '144', 'groupId': 'BG005'}, {'value': '146', 'groupId': 'BG006'}, {'value': '997', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-bronchodilator FEV1 percentage of predicted normal (PN) at randomization', 'classes': [{'categories': [{'measurements': [{'value': '70.03', 'spread': '10.544', 'groupId': 'BG000'}, {'value': '68.86', 'spread': '11.580', 'groupId': 'BG001'}, {'value': '68.86', 'spread': '11.774', 'groupId': 'BG002'}, {'value': '68.56', 'spread': '12.186', 'groupId': 'BG003'}, {'value': '67.28', 'spread': '11.732', 'groupId': 'BG004'}, {'value': '69.06', 'spread': '12.132', 'groupId': 'BG005'}, {'value': '68.52', 'spread': '11.319', 'groupId': 'BG006'}, {'value': '68.73', 'spread': '11.615', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of predicted normal', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total daily dose of inhaled glucocorticosteroids (ICS)', 'classes': [{'categories': [{'measurements': [{'value': '406.31', 'groupId': 'BG000', 'lowerLimit': '125.0', 'upperLimit': '1000.0'}, {'value': '399.75', 'groupId': 'BG001', 'lowerLimit': '100.0', 'upperLimit': '1000.0'}, {'value': '413.70', 'groupId': 'BG002', 'lowerLimit': '125.0', 'upperLimit': '1000.0'}, {'value': '396.46', 'groupId': 'BG003', 'lowerLimit': '150.0', 'upperLimit': '500.0'}, {'value': '405.56', 'groupId': 'BG004', 'lowerLimit': '160.0', 'upperLimit': '1000.0'}, {'value': '418.19', 'groupId': 'BG005', 'lowerLimit': '125.0', 'upperLimit': '1000.0'}, {'value': '410.99', 'groupId': 'BG006', 'lowerLimit': 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'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-11', 'studyFirstSubmitDate': '2010-09-08', 'resultsFirstSubmitDate': '2013-07-01', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-01', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-bronchodilator FEV1 at the Clinic', 'timeFrame': 'Twelve week treatment period', 'description': 'Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.'}], 'secondaryOutcomes': [{'measure': 'Morning and Evening PEF', 'timeFrame': 'Twelve week treatment period', 'description': 'Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.'}, {'measure': 'Asthma Control Questionnaire 5-item (ACQ5)', 'timeFrame': 'Twelve week treatment period', 'description': 'The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.'}, {'measure': 'Adverse Events', 'timeFrame': 'Twelve week treatment period', 'description': 'Number of participants who had at least one adverse event during the randomized treatment period'}, {'measure': 'Number of Participants With at Least One Severe Asthma Exacerbation', 'timeFrame': 'Twelve week treatment period', 'description': 'Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days'}, {'measure': 'Number of Participants With at Least One Treatment Failure', 'timeFrame': 'Twelve week treatment period', 'description': 'Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.'}, {'measure': 'Number of Participants With Well-controlled Asthma (ACQ5<=0.75)', 'timeFrame': 'Twelve week treatment period', 'description': 'The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5\\<=0.75 at the end of the 12-week treatment period.'}, {'measure': 'Asthma Quality of Life Questionnaire (AQLQ(S))', 'timeFrame': 'Twelve week treatment period', 'description': 'The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.'}, {'measure': 'Asthma Symptom Score', 'timeFrame': 'Twelve week treatment period', 'description': 'Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.'}, {'measure': 'Total Reliever Medication Use', 'timeFrame': 'Twelve week treatment period', 'description': 'Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Efficacy', 'safety', 'tolerability', 'dose finding', 'asthma patients'], 'conditions': ['Asthma Patients']}, 'referencesModule': {'references': [{'pmid': '29765200', 'type': 'DERIVED', 'citation': "Bateman ED, O'Brien C, Rugman P, Luke S, Ivanov S, Uddin M. Efficacy and safety of the CRTh2 antagonist AZD1981 as add-on therapy to inhaled corticosteroids and long-acting beta2-agonists in patients with atopic asthma. Drug Des Devel Ther. 2018 May 4;12:1093-1106. doi: 10.2147/DDDT.S147389. eCollection 2018."}]}, 'descriptionModule': {'briefSummary': 'The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception\n* 6 months history of asthma according to ATS definition\n* Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2\n* Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal\n* A total ACQ5 score of 1.5 or more\n\nExclusion Criteria:\n\n* Respiratory infection significantly affecting the asthma\n* Any significant disease and disorder that may put the patient at risk or influence study results\n* Any clinically relevant abnormal findings\n* A smoking history of more than 10 pack years\n* Intake of oral, rectal or parenteral glucocorticosteroids'}, 'identificationModule': {'nctId': 'NCT01197794', 'acronym': 'Sweapea', 'briefTitle': 'Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients', 'orgStudyIdInfo': {'id': 'D9830C00008'}, 'secondaryIdInfos': [{'id': '2010-020407-73', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD1981 10 mg', 'description': 'AZD1981 10 mg', 'interventionNames': ['Drug: AZD1981']}, {'type': 'EXPERIMENTAL', 'label': 'AZD1981 40 mg', 'description': 'AZD1981 40 mg', 'interventionNames': ['Drug: AZD1981']}, {'type': 'EXPERIMENTAL', 'label': 'AZD1981 100 mg', 'description': 'AZD1981 100 mg', 'interventionNames': ['Drug: AZD1981']}, {'type': 'EXPERIMENTAL', 'label': 'AZD1981 400 mg', 'description': 'AZD1981 400 mg', 'interventionNames': ['Drug: AZD1981']}, {'type': 'EXPERIMENTAL', 'label': 'AZD1981 80 mg', 'description': 'AZD1981 80 mg', 'interventionNames': ['Drug: AZD1981']}, {'type': 'EXPERIMENTAL', 'label': 'AZD1981 200 mg', 'description': 'AZD1981 200 mg', 'interventionNames': ['Drug: AZD1981']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1981', 'type': 'DRUG', 'description': 'AZD1981 twice daily', 'armGroupLabels': ['AZD1981 10 mg', 'AZD1981 100 mg', 'AZD1981 40 mg', 'AZD1981 400 mg']}, {'name': 'AZD1981', 'type': 'DRUG', 'description': 'AZD1981 once daily', 'armGroupLabels': ['AZD1981 200 mg', 'AZD1981 80 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match AZD1981', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, 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