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NCT04053634 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 689
- Enrollment target
NCT04053634: Completed Phase 3 study, sponsored by AstraZeneca.
NCT04053634 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 689 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04053634, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 689 participants
- Enrollment target
Study Summary
Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count. The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.
Primary Outcome
Moderate or severe COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; and/or * Use of antibiotics; and/or * An inpatient hospitalization or death due to COPD
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Benralizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 689 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2025-07-28 |
| Phase | Phase 3 |
What the finished NCT04053634 record still lists
NCT04053634 is an interventional study that assigns participants to a tested intervention. The registered 689 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 (11% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04053634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04053634 about?
NCT04053634 is a clinical study titled "Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations". Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations ...
What is the current status of trial NCT04053634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 689 participants. The study started on 2019-08-26. Estimated completion is 2025-07-28.
What interventions are being tested in trial NCT04053634?
The interventions under investigation include: Placebo (BIOLOGICAL), Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04053634?
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 NCT04053634's enrollment target sits among peer trials
689 525th of 2000 higher than 1,476 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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