At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,020 enrolled
Drug / intervention
Fluticasone Furoate/GW642444 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Fluticasone Furoate/GW642444 and Fluticasone furoate for Asthma. Completed, enrolled 2,020 participants across 183 sites in 11 countries.
Detailed Summary
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Germany, Japan, Mexico, Philippines, Poland, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedMar 2010
Primary CompletionSep 2011
Study CompletionSep 2011
TodayJul 2026
First PostedMar 15, 2010
Enrollment StartFeb 22, 2010
Primary CompletionSep 1, 2011
Study CompletionSep 15, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.3 years ago
Interventions
Fluticasone Furoate/GW642444drug
Combination inhaled corticosteroid and long-acting beta2-agonist
Fluticasone furoatedrug
Inhaled corticosteroid