CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 700 enrolled
Drug / intervention
Fluticasone Propionate 100mcg via ACCUHALER/DISKUS +9 moredrug
Likely dose
Fluticasone Propionate 100mcg via ACCUHALER/DISKUSfrom 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/NCT01147744
NCT01147744Phase 2Completed
CompareCT.gov

A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Once Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma While Treated With Short Acting Beta2-agonist.

GlaxoSmithKline·interventional·Posted Jun 22, 2010·Updated Oct 2, 2017

In Brief

A Phase 2 clinical trial evaluating Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, and 8 other interventions for Asthma. Completed, enrolled 700 participants across 84 sites in 6 countries.

Detailed Summary

To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Japan, Poland, Romania, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartJun 28, 2010
Primary CompletionOct 6, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.0 years ago

Interventions

Fluticasone Propionate 100mcg via ACCUHALER/DISKUSdrug

Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS

GSK2190915 100mgdrug

GSK2190915 100mg (1 x 100mg) once daily in the morning

GSK2190915 10mgdrug

GSK2190915 10mg (1 x 10mg) once daily in the morning

GSK2190915 300mgdrug

GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning

GSK2190915 30mgdrug

GSK2190915 30mg (1 x 30mg) once daily in the morning

Montelukast 10mgdrug

Montelukast 10mg (1 x 10mg capsule) once daily in the evening

Placebo GSK2190915 one tabletdrug

Placebo tablet, one tablet once daily in the morning

Placebo montelukastdrug

Placebo capsule once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUSdrug

Inhaled placebo twice daily via ACCUHALER/DISKUS

Placebo GSK2190915 two tabletsdrug

Placebo tablet, two tablets once daily in the morning