drugset / Trial / NCT05363202

To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma

NCT05363202

Phase 3 Unknown 790 enrolled Glenmark Pharmaceuticals Ltd. India
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd) to Flovent HFA (fluticasone propionate inhalation aerosol) 44 mcg (GSK group of companies) in treatment of patients with bronchial asthma.

Timeline

Start
2022-04-15
Primary completion
2024-05-30
Completion
2024-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 44 ug Inhaled

Indications