CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,233 enrolled
Drug / intervention
fluticasone furoate + vilanterol +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.

Search/NCT01706198
NCT01706198Phase 3Completed

A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler Compared With Usual Maintenance Therapy in Subjects With Asthma

GlaxoSmithKline·interventional·Posted Oct 15, 2012·Updated Jan 24, 2019

In Brief

A Phase 3 clinical trial evaluating fluticasone furoate + vilanterol and inhaled corticosteroid with or without a long acting beta2-agonist for Asthma. Completed, enrolled 4,233 participants across 180 sites.

Detailed Summary

This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2016
Study CompletionDec 16, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.7 years ago

Interventions

fluticasone furoate + vilanteroldrug

once daily via a Novel Dry Powder Inhaler

inhaled corticosteroid with or without a long acting beta2-agonistdrug

ICS alone or in combination with a long acting bronchodilator