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Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH — QVR  

Bronchial Asthma Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of improvement in FEV1 measured before and after 4 weeks of treatment in adult patients with chronic stable asthma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04051710
Study type Interventional
Source Aurobindo Pharma Ltd
Contact
Status Completed
Phase Phase 3
Start date March 12, 2019
Completion date December 20, 2019
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