Trial · NCT04053634
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
NCT04053634, Phase 3, Completed, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations. Trials, record NCT04053634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04053634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
- NCT number
- NCT04053634
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 689 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Benralizumab, Placebo
- First posted
- 2019-08-12
- Last updated
- 2025-08-19
- Other registries' IDs
- eudract:2019-001800-39
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized rate of moderate or severe COPD exacerbations | Over first 56 weeks | 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 |
| Secondary | Annualized rate of severe COPD exacerbations | Minimum of 1 year and an average of 2 years | A severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD |
| Secondary | Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization | Minimum of 1 year and an average of 2 years | |
| Secondary | Time to first COPD exacerbation | During first 56 weeks | |
| Secondary | Change from baseline in SGRQ total and domain scores | up to 56 weeks | St. George's Respiratory Questionnaire (SGRQ) |
| Secondary | Change from baseline in E-RS:COPD total and domain scores | up to 56 weeks | Evaluating Respiratory Symptoms in COPD (E-RS:COPD) |
| Secondary | Change from baseline in pre-dose/pre-bronchodilator FEV1 | up to 56 weeks | FEV1 is the Forced expiratory volume in one second at study site |
| Secondary | All cause and respiratory-related mortality rate | Minimum of 1 year and an average of 2 years | |
| Secondary | Annual rate of hospitalizations due to COPD | Minimum of 1 year and an average of 2 years | |
| Secondary | Serum benralizumab concentration as a measure of pharmacokinetics | up to 56 weeks |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04053634
GET https://conductscience.org/api/trials/v1/NCT04053634/registered