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NCT02138916 · ClinicalTrials.gov registry record · Phase 3

Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
1,656
Enrollment target

NCT02138916: Completed Phase 3 study, sponsored by AstraZeneca.

NCT02138916 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,656 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (115% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02138916, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
1,656 participants
Enrollment target

Study Summary

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

Primary Outcome

A COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or * Use of antibiotics; and/or * An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment peri

Interventions

  • DRUG Placebo
  • DRUG Benralizumab Arm A
  • DRUG Benralizumab Arm B

Trial Details

FieldValue
Enrollment Target 1,656 participants
Start Date 2014-06-13
Est. Completion 2018-04-10
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02138916 record still lists

NCT02138916 is an interventional study that assigns participants to a tested intervention. Its 1,656 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (115% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02138916 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02138916 about?

NCT02138916 is a clinical study titled "Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History". The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies

What is the current status of trial NCT02138916?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,656 participants. The study started on 2014-06-13. Estimated completion is 2018-04-10.

What interventions are being tested in trial NCT02138916?

The interventions under investigation include: Placebo (DRUG), Benralizumab Arm A (DRUG), Benralizumab Arm B (DRUG).

Who is sponsoring clinical trial NCT02138916?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02138916's enrollment target sits among peer trials

1,656 137th of 2000 higher than 1,863 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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Source: ClinicalTrials.gov NCT02138916, the US trial registry maintained by the National Library of Medicine. NCT02138916 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.