drugset / Trial / NCT01479621

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

NCT01479621

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.

Timeline

Start
2012-01
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 12.5 ug Inhaled
Subject Fluticasone propionate Other / unclassified 25 ug Inhaled
Subject Fluticasone propionate Other / unclassified 50 ug Inhaled
Subject Fluticasone propionate Other / unclassified 100 ug Inhaled
Background Salbutamol Unknown Inhaled

Indications