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NCT02281318 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 556
- Enrollment target
NCT02281318 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 556 participants.
The verdict
NCT02281318, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 556 participants
- Enrollment target
Study Summary
This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function. Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.
Interventions
- DRUG Placebo
- BIOLOGICAL Mepolizumab
- DRUG SOC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2014-12-11 |
| Est. Completion | 2016-06-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02281318
The ClinicalTrials.gov registry entry for NCT02281318 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02281318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02281318 about?
NCT02281318 is a clinical study titled "Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Participants With Severe Eosinophilic Asthma on Markers of Asthma Control". This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impa...
What is the current status of trial NCT02281318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 556 participants. The study started on 2014-12-11. Estimated completion is 2016-06-10.
What interventions are being tested in trial NCT02281318?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (BIOLOGICAL), SOC (DRUG).
Who is sponsoring clinical trial NCT02281318?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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