Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01156792 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
NCT01156792: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01156792 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 162 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01156792, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
Study Summary
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.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mix
Interventions
- DRUG placebo
- DRUG montelukast
- DRUG FP 100
- DRUG GSK2190915 100
- DRUG GSK2190915 300
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT01156792 record still lists
NCT01156792 is an interventional study that assigns participants to a tested intervention. The registered 162 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 (22% higher).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT01156792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01156792 about?
NCT01156792 is a clinical study titled "Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age". 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 ...
What is the current status of trial NCT01156792?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2010-09. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01156792?
The interventions under investigation include: placebo (DRUG), montelukast (DRUG), FP 100 (DRUG), GSK2190915 100 (DRUG), GSK2190915 300 (DRUG).
Who is sponsoring clinical trial NCT01156792?
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 NCT01156792's enrollment target sits among peer trials
162 418th of 2000 higher than 1,579 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02347111 · 162 participants · Phase 4
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
- NCT02610426 · 162 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer
- NCT05040711 · 162 participants · NA
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
- NCT05514717 · 162 participants · Phase 1
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia