At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,550 enrolled
Drug / intervention
Test Product +2 moredrug
Likely dose
Test Product 40 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy and Safety of Beclomethasone Dipropionate Metered Dose Inhaler (Inhalation Aerosol) (0.04mg/ INH) in Male and/ or Female Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Test Product, Reference Product, and 1 other intervention for Bronchial Asthma. Completed, enrolled 1,550 participants across 1 site.
Detailed Summary
To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchial Asthma
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartMar 2019
First PostedAug 2019
Primary CompletionAug 2019
Study CompletionDec 2019
TodayJul 2026
First PostedAug 9, 2019
Enrollment StartMar 12, 2019
Primary CompletionAug 29, 2019
Study CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.9 years ago
Interventions
Test Productdrug
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
Reference Productdrug
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
Placebodrug
Placebo Product