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NCT02869438 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
NCT02869438: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02869438 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 233 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02869438, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.
Primary Outcome
The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
Interventions
- OTHER Placebo
- DRUG Benralizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2016-11-09 |
| Est. Completion | 2018-08-01 |
| Phase | Phase 3 |
What the finished NCT02869438 record still lists
NCT02869438 is an interventional study that assigns participants to a tested intervention. The registered 233 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 (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02869438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02869438 about?
NCT02869438 is a clinical study titled "A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation". The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients w...
What is the current status of trial NCT02869438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2016-11-09. Estimated completion is 2018-08-01.
What interventions are being tested in trial NCT02869438?
The interventions under investigation include: Placebo (OTHER), Benralizumab (DRUG).
Who is sponsoring clinical trial NCT02869438?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02869438's enrollment target sits among peer trials
233 1298th of 2000 higher than 703 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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