NCT04051710

Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,550 (actual)
• Sponsor: Aurobindo Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Test Product	Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
DRUG	Reference Product	Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
DRUG	Placebo	Placebo Product

Timeline

• Start date: 2019-03-12
• Primary completion: 2019-08-29
• Completion: 2019-12-20
• First posted: 2019-08-09
• Last updated: 2020-11-13
• Results posted: 2020-11-13

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study