At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIb, 24 Week, Randomized, Double-blind, 3 Arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of Two Doses of Umeclidinium Bromide Administered Once-daily Via a Dry Powder Inhaler, Versus Placebo, in Participants With Asthma
In Brief
A Phase 2 clinical trial evaluating Placebo, UMEC, and 2 other interventions for Asthma. Completed, enrolled 425 participants across 70 sites in 5 countries.
Detailed Summary
This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment. This study will provide important information regarding the efficacy and safety of UMEC when administered in a separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase IIb, randomized, double-blind, placebo controlled study that will compare the efficacy, safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects with asthma that is not well controlled. Eligible subjects will be requested to participate in the study for a maximum of approximately 31 weeks with 4 phases (pre screening, screening/run-in, randomization/treatment and safety follow-up). The total number of randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each of the 3 double-blind treatment arms.
Study Details
Timeline
Interventions
Placebo is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, both of which contains lactose monohydrate blended with magnesium stearate.
UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate.
FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate.
Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study.