CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 348 enrolled
Drug / intervention
Vilanterol +3 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/NCT01181895
NCT01181895Phase 3Completed

A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids

GlaxoSmithKline·interventional·Posted Aug 13, 2010·Updated Nov 8, 2017

In Brief

A Phase 3 clinical trial evaluating Vilanterol, Salmeterol Inhalation Powder, and 2 other interventions for Asthma. Completed, enrolled 348 participants across 34 sites in 5 countries.

Detailed Summary

The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany, Peru, Poland, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2010
Enrollment StartSep 1, 2010
Primary CompletionAug 1, 2011
Study CompletionAug 26, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.9 years ago

Interventions

Vilanteroldrug

Vilanterol inhalation powder inhaled orally once daily for 12 weeks

Salmeterol Inhalation Powderdrug

Salmeterol inhalation powder inhaled orally twice daily for 12 weeks

Placebo Inhalation Powder NDPIdrug

Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Placebo Inhalation Powder Diskusdrug

Placebo inhalation powder inhaled orally twice daily for 12 weeks