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NCT01147744 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
NCT01147744: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01147744 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 700 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (426% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01147744, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
Study 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.
Primary Outcome
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comp
Interventions
- DRUG Fluticasone Propionate 100mcg via ACCUHALER/DISKUS
- DRUG GSK2190915 100mg
- DRUG GSK2190915 10mg
- DRUG GSK2190915 300mg
- DRUG GSK2190915 30mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2010-06-28 |
| Est. Completion | 2011-10-06 |
| Phase | Phase 2 |
What the finished NCT01147744 record still lists
NCT01147744 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (426% higher).
The record links to 0 conditions, and to 5 interventions - of which Fluticasone Propionate 100mcg via ACCUHALER/DISKUS is the first listed.
NCT01147744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01147744 about?
NCT01147744 is a clinical study titled "Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily". 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 ...
What is the current status of trial NCT01147744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2010-06-28. Estimated completion is 2011-10-06.
What interventions are being tested in trial NCT01147744?
The interventions under investigation include: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS (DRUG), GSK2190915 100mg (DRUG), GSK2190915 10mg (DRUG), GSK2190915 300mg (DRUG), GSK2190915 30mg (DRUG).
Who is sponsoring clinical trial NCT01147744?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01147744's enrollment target sits among peer trials
700 46th of 2000 higher than 1,955 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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