Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
Public ClinicalTrials.gov record NCT01147744. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01147744
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Interventions
- Fluticasone Propionate 100mcg via ACCUHALER/DISKUS Drug
- GSK2190915 100mg Drug
- GSK2190915 10mg Drug
- GSK2190915 300mg Drug
- GSK2190915 30mg Drug
- Montelukast 10mg Drug
- Placebo GSK2190915 one tablet Drug
- Placebo montelukast Drug
- Placebo fluticasone propionate via ACCUHALER/DISKUS Drug
- Placebo GSK2190915 two tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 28, 2010 (Actual)
- Primary completion
- Oct 6, 2011 (Actual)
- Completion
- Oct 6, 2011 (Actual)
- Last update posted
- Oct 2, 2017
2010 – 2011
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | — |
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | San Diego | California | 92123 | — |
| GSK Investigational Site | Tallahassee | Florida | 32308 | — |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | — |
| GSK Investigational Site | Metairie | Louisiana | 70006 | — |
| GSK Investigational Site | Bangor | Maine | 04401 | — |
| GSK Investigational Site | Ypsilanti | Michigan | 48197 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | — |
| GSK Investigational Site | Columbia | Missouri | 65203 | — |
| GSK Investigational Site | Rolla | Missouri | 65401 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Ocean City | New Jersey | 07712 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Waco | Texas | 76712 | — |
| GSK Investigational Site | Bellingham | Washington | 98225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01147744, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2017 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01147744 live on ClinicalTrials.gov.