Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
Public ClinicalTrials.gov record NCT01156792. 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 Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment. The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.
Study identification
- NCT ID
- NCT01156792
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 162 participants
Conditions and interventions
Conditions
Interventions
- FP 100 Drug
- GSK2190915 100 Drug
- GSK2190915 300 Drug
- montelukast Drug
- placebo Drug
- FP/SAL 100/50 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
- Sep 2010 (Type not available)
- Primary completion
- Oct 2011 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Apr 5, 2017
2010 – 2011
United States locations
- U.S. sites
- 32
- U.S. states
- 22
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | Vista | California | 92083 | — |
| GSK Investigational Site | Coral Gables | Florida | 33134 | — |
| GSK Investigational Site | Miami | Florida | 33173 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | — |
| GSK Investigational Site | Lenexa | Kansas | 66215 | — |
| 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 | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Bellevue | Nebraska | 68123-4303 | — |
| GSK Investigational Site | Ocean City | New Jersey | 07712 | — |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| GSK Investigational Site | Bethlehem | Pennsylvania | 18020 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Austin | Texas | 78750 | — |
| GSK Investigational Site | Dallas | Texas | 75230 | — |
| GSK Investigational Site | Houston | Texas | 77054 | — |
| GSK Investigational Site | Plano | Texas | 75024 | — |
| GSK Investigational Site | Waco | Texas | 76712 | — |
| GSK Investigational Site | South Burlington | Vermont | 05403 | — |
| GSK Investigational Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01156792, 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 Apr 5, 2017 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01156792 live on ClinicalTrials.gov.