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NCT01691508 · ClinicalTrials.gov registry record · Phase 3
Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma
A Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT01691508 is a Phase 3 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 135 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT01691508, a Phase 3 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100 mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase subjects will be maintained without any further OCS dose adjustment. Subjects who complete the 24 week double-blind period and meet the eligibility criteria, will be offered the opportunity to participate in an open label extension (OLE) study otherwise they will return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment. At each clinic visit, adverse events, safety labs, spirometery parameters
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mepolizumab
- DRUG OCS (prednisone/prednisolone)
Study Locations (20)
Other
- GSK Investigational Site - Brno
- GSK Investigational Site - Olomouc
- GSK Investigational Site - Prague
- GSK Investigational Site - Prague
Quebec
- GSK Investigational Site - Montreal
- GSK Investigational Site - Montreal
- GSK Investigational Site - Québec
California
- GSK Investigational Site - Long Beach
Colorado
- GSK Investigational Site - Denver
Connecticut
- GSK Investigational Site - New Haven
Minnesota
- GSK Investigational Site - Rochester
Missouri
- GSK Investigational Site - St Louis
Ohio
- GSK Investigational Site - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01691508
The ClinicalTrials.gov registry entry for NCT01691508 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (91% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01691508 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Quebec, California.
Frequently Asked Questions
What is clinical trial NCT01691508 about?
NCT01691508 is a clinical study titled "Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma". This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase (Week -8 to Week 0), and ...
What is the current status of trial NCT01691508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2012-10. Estimated completion is 2013-12.
What conditions does trial NCT01691508 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01691508?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (DRUG), OCS (prednisone/prednisolone) (DRUG).
Who is sponsoring clinical trial NCT01691508?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01691508 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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