Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-28 @ 8:02 AM
Study NCT ID:
NCT00964535
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2009-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D019819', 'term': 'Budesonide'}, {'id': 'D001239', 'term': 'Inhalation'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-12', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations', 'timeFrame': 'within 24 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females aged 18-60 years with documented diagnosis of asthma\n* Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value\n* The asthma should be stable on the same regular treatment for at least 4 weeks before screening.\n\nExclusion Criteria:\n\n* Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening\n* Respiratory infection within 4 weeks preceding the screening\n* Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide\n* Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study'}, 'identificationModule': {'nctId': 'NCT00964535', 'acronym': 'KINECO', 'briefTitle': 'Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation', 'orgStudyIdInfo': {'id': '3103002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Budesonide/formoterol Easyhaler', 'interventionNames': ['Drug: budesonide and formoterol 200/6 microg']}, {'type': 'EXPERIMENTAL', 'label': 'Charcoal and Budesonide/formoterol EH', 'interventionNames': ['Drug: budesonide and formoterol 200/6 microg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Symbicort Turbohaler', 'interventionNames': ['Drug: budesonide and formoterol 200/6 microg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Charcoal and Symbicort Turbohaler', 'interventionNames': ['Drug: budesonide and formoterol 200/6 microg']}], 'interventions': [{'name': 'budesonide and formoterol 200/6 microg', 'type': 'DRUG', 'otherNames': ['Budesonide/formoterol Easyhaler 200/6 microg/inhalation'], 'description': '2 inhalations as a single dose', 'armGroupLabels': ['Budesonide/formoterol Easyhaler']}, {'name': 'budesonide and formoterol 200/6 microg', 'type': 'DRUG', 'otherNames': ['Symbicort Turbohaler 200/6 microg/inhalation'], 'description': '2 inhalations as a single dose', 'armGroupLabels': ['Symbicort Turbohaler']}, {'name': 'budesonide and formoterol 200/6 microg', 'type': 'DRUG', 'otherNames': ['Budesonide/formoterol Easyhaler 200/6 microg/inhalation'], 'description': '2 inhalations as a single dose with the concurrent charcoal blockage', 'armGroupLabels': ['Charcoal and Budesonide/formoterol EH']}, {'name': 'budesonide and formoterol 200/6 microg', 'type': 'DRUG', 'otherNames': ['Symbicort Turbohaler 200/6 microg/inhalation'], 'description': '2 inhalations as a single dose with the concurrent charcoal blockage', 'armGroupLabels': ['Charcoal and Symbicort Turbohaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9QZ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Medicines Evaluation Unit', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Ulla Sairanen, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orion Corporation, Orion Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ulla Sairanen', 'oldOrganization': 'Orion Corporation, Orion Pharma'}}}}