drugset / Trial / NCT03562949

A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol

NCT03562949

Phase 3 Terminated 761 enrolled Amneal Ireland Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

Timeline

Start
2018-12-06
Primary completion
2019-08-02
Completion
2019-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject beclomethasone dipropionate Other / unclassified 40 ug Inhaled

Indications