Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06154304
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2023-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation 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': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-11-23', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)', 'timeFrame': '1 day', 'description': '• To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) \\[InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720\\] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': 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\n1. Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)\n2. Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC\n\n a. If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is \\<80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)\n3. Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC\n4. Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.\n\nExclusion Criteria:\n\n1\\. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT06154304', 'briefTitle': 'BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation 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': 'CRD/58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Product', 'description': 'One actuation each from four different placebo inhalation aerosols.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product', 'description': 'One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols', 'interventionNames': ['Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference 90mcg Product', 'description': 'One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols.', 'interventionNames': ['Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference 180mcg Product', 'description': 'One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols', 'interventionNames': ['Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2']}], 'interventions': [{'name': 'Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)', 'type': 'DRUG', 'otherNames': ['Albuterol Test Product'], 'description': '90 mcg', 'armGroupLabels': ['Test Product']}, {'name': 'Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1', 'type': 'DRUG', 'otherNames': ['Albuterol Reference Product'], 'description': '90 mcg', 'armGroupLabels': ['Reference 90mcg Product']}, {'name': 'Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2', 'type': 'DRUG', 'otherNames': ['Albuterol Reference Product'], 'description': '180 mcg', 'armGroupLabels': ['Reference 180mcg Product']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Velocity CLinical Research', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}], 'overallOfficials': [{'name': 'Sarah Smiley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Velocity Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cipla Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}