Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 3:40 AM
Study NCT ID:
NCT02624505
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2015-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.', 'detailedDescription': 'This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and non-pregnant female subjects (18-65 years of age)\n* Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.\n* Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.\n* Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).\n* Written informed consent.\n\nExclusion Criteria:\n\n* Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.\n* History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.\n* History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.\n* History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma\n* Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases\n* Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).'}, 'identificationModule': {'nctId': 'NCT02624505', 'briefTitle': 'Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cipla Ltd.'}, 'officialTitle': 'To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.', 'orgStudyIdInfo': {'id': 'U-SS-M-AS312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Product', 'description': 'One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '90 mcg Reference Product', 'description': 'Drug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols', 'interventionNames': ['Drug: 90 mcg Reference Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': '180 mcg Reference Product', 'description': 'Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols', 'interventionNames': ['Drug: 180 mcg Reference Product']}, {'type': 'EXPERIMENTAL', 'label': '90 mcg Test Product', 'description': 'Drug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols', 'interventionNames': ['Drug: 90 mcg Test Product']}], 'interventions': [{'name': '90 mcg Reference Product', 'type': 'DRUG', 'otherNames': ['Albuterol'], 'description': 'Drug: 90 mcg Reference Product', 'armGroupLabels': ['90 mcg Reference Product']}, {'name': '180 mcg Reference Product', 'type': 'DRUG', 'otherNames': ['Albuetrol'], 'description': 'Drug: 180 mcg of Reference Product', 'armGroupLabels': ['180 mcg Reference Product']}, {'name': '90 mcg Test Product', 'type': 'DRUG', 'otherNames': ['Albuterol'], 'description': 'Drug: 90 mcg of Test Product', 'armGroupLabels': ['90 mcg Test Product']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Product', 'armGroupLabels': ['Placebo Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Allergy and Asthma Centers', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Dhiraj Abhyankar', 'role': 'STUDY_CHAIR', 'affiliation': 'Cipla Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cipla Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}