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NCT04133909 · ClinicalTrials.gov registry record · Phase 3
Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 806
- Enrollment target
NCT04133909: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04133909 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 806 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04133909, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 806 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.
Primary Outcome
Annualized rate of moderate or severe exacerbations were assessed. Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral or systemic corticosteroids and/or antibiotics. Severe exacerbations are defined per protocol as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death.
Interventions
- DRUG Placebo
- BIOLOGICAL Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 806 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2024-08-08 |
| Phase | Phase 3 |
What the finished NCT04133909 record still lists
NCT04133909 is an interventional study that assigns participants to a tested intervention. The registered 806 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04133909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04133909 about?
NCT04133909 is a clinical study titled "Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level". This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD...
What is the current status of trial NCT04133909?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 806 participants. The study started on 2019-10-30. Estimated completion is 2024-08-08.
What interventions are being tested in trial NCT04133909?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04133909?
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 NCT04133909's enrollment target sits among peer trials
806 411th of 2000 higher than 1,590 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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