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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02281318 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 556 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
SGRQ consisted of 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure Quality of Life in par. with diseases of airway obstruction, measuring symptoms, impact, and activity. Questions were completed by the par. with a recall over the past 4 weeks. SGRQ Total Score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100 to get a %. Change from BL in S
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 |
What the finished NCT02281318 record still lists
NCT02281318 is an interventional study that assigns participants to a tested intervention. The registered 556 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02281318 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02281318's enrollment target sits among peer trials
556 675th of 2000 higher than 1,325 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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