drugset / Trial / NCT02040779

A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

NCT02040779

Phase 3 Completed 273 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Timeline

Start
2013-12-26
Primary completion
2014-12-24
Completion
2014-12-24

Drugs

EvaluationDrugModalityDoseRoute
Subject beclomethasone dipropionate Other / unclassified 80 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 160 ug Inhaled
Background Salbutamol Unknown Inhaled

Indications