drugset / Trial / NCT01159912

Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents

NCT01159912 ↗

Phase 3 Completed 350 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

Timeline

Start
2010-06-30
Primary completion
2012-01-01
Completion
2012-01-16

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs FF 100 µg OD; p = 0.009; Mean Difference (Final Values) 0.146 (95% CI 0.036 to 0.257); ANCOVA NCT01159912 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Furoate Other / unclassified 100 ug Inhaled
Comparator Fluticasone propionate Other / unclassified 250 ug Inhaled

Indications