drugset / Trial / NCT01498653

Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry

NCT01498653 ↗

Phase 3 Completed 313 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination therapy

Timeline

Start
2012-01
Primary completion
2013-02
Completion
2013-02

Outcome

Met primary endpoint

paper the adjusted mean treatment difference for FF/VI versus FP of 28.5 L/min (95% confidence interval [CI]: 20.1, 36.9) was clinically and statistically significant (p < 0.001). PMID 25524507 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Furoate Other / unclassified 200 ug Inhaled
Comparator Fluticasone propionate Other / unclassified 500 ug Inhaled
Subject Vilanterol Other / unclassified 25 ug Inhaled

Indications