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NCT01000506 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 621
- Enrollment target
NCT01000506: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01000506 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 621 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (367% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01000506, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 621 participants
- Enrollment target
Study Summary
The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.
Primary Outcome
Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids \[OCS\], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatme
Interventions
- DRUG Placebo saline
- BIOLOGICAL Mepolizumab 750
- BIOLOGICAL Mepolizumab 250
- BIOLOGICAL Mepolizumab 75
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 621 participants |
| Start Date | 2009-11-01 |
| Est. Completion | 2012-03-23 |
| Phase | Phase 2 |
What the finished NCT01000506 record still lists
NCT01000506 is an interventional study that assigns participants to a tested intervention. The registered 621 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 (367% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo saline is the first listed.
NCT01000506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01000506 about?
NCT01000506 is a clinical study titled "Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma". The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comp...
What is the current status of trial NCT01000506?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 621 participants. The study started on 2009-11-01. Estimated completion is 2012-03-23.
What interventions are being tested in trial NCT01000506?
The interventions under investigation include: Placebo saline (DRUG), Mepolizumab 750 (BIOLOGICAL), Mepolizumab 250 (BIOLOGICAL), Mepolizumab 75 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01000506?
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 NCT01000506's enrollment target sits among peer trials
621 52nd of 2000 higher than 1,949 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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