A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate (FF/VI) Inhalation Powder Delivered Once Daily for 12 Weeks in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry Currently Treated With Low to Mid-strength Inhaled Corticosteroid or Low-strength Combination Therapy.

NCT01498679 Phase 3 COMPLETED Results posted

A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid or low-strength combination therapy.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	311
Start date	2012-01
Completion	2013-07

Conditions

• Asthma

Interventions

• GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
• Placebo

Primary outcomes

• Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period — Baseline and Weeks 1-12 (up to Day 84)
  Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.

Countries

China, Philippines, South Korea