Trial · NCT02138916
Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
NCT02138916, Phase 3, Completed, AstraZeneca; results first posted 2019-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History. Trials, record NCT02138916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02138916
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
- NCT number
- NCT02138916
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,656 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Moderate to Very Severe Chronic Obstructive Pulmonary Disease
- Interventions
- Benralizumab Arm A, Benralizumab Arm B, Placebo
- First posted
- 2014-05-15
- Last updated
- 2019-06-13
- Results first posted
- 2019-06-13
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | From first IP to week 56 | 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 period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model. |
| Secondary | Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL | From first IP to week 56 | 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 period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model. |
| Secondary | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL | First IP up to end of treatment Week 56 | Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment. |
| Secondary | Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status. |
| Secondary | Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status. |
| Secondary | Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity. |
| Secondary | Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use. |
| Secondary | Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Change from baseline to week 56 in proportion of nights awakenings due to respiratory symptoms. |
| Secondary | Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Exacerbation event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an exacerbation event has occurred. |
| Secondary | Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity for the study is the highest score of EXACT-PRO. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | From first IP to week 56 | Full analysis set with baseline EOS\>=220/uL | Exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL | From first IP to week 56 | Full analysis set with baseline EOS\<220/uL | Exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL | First IP up to end of treatment Week 56 | Full analysis set, baseline EOS\>=220/uL | Liter | MEAN |
| SECONDARY | Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Percentage | MEAN |
| SECONDARY | Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Puffs/day | MEAN |
| SECONDARY | Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Proportion of nights | MEAN |
| SECONDARY | Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | Full analysis set, EOS\>=220/uL | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | Full analysis set, baseline EOS\>=220/uL | Score on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group127
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | Benralizumab 30 mg | 1.19 | 95% Confidence Interval 1.04 to 1.36 | Exacerbations per year | |
| Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | Benralizumab 100 mg | 1.03 | 95% Confidence Interval 0.9 to 1.19 | Exacerbations per year | |
| Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | Placebo | 1.24 | 95% Confidence Interval 1.08 to 1.42 | Exacerbations per year | |
| Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL | Benralizumab 30 mg | 1.4 | 95% Confidence Interval 1.19 to 1.64 | Exacerbations per year | |
| Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL | Benralizumab 100 mg | 1.32 | 95% Confidence Interval 1.12 to 1.56 | Exacerbations per year | |
| Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL | Placebo | 1.30 | 95% Confidence Interval 1.11 to 1.52 | Exacerbations per year | |
| Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL | Benralizumab 30 mg | 0.014 | Standard Deviation 0.282 | Liter | |
| Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL | Benralizumab 100 mg | 0.031 | Standard Deviation 0.294 | Liter | |
| Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL | Placebo | 0.010 | Standard Deviation 0.275 | Liter | |
| Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL | Benralizumab 30 mg | -5.025 | Standard Deviation 14.677 | Percentage |
1 to 10 of 127Source ClinicalTrials.gov
See all 127 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab 30 mg | 554 | |
| Overall Study | STARTED | Benralizumab 100 mg | 552 | |
| Overall Study | STARTED | Placebo | 550 | |
| Overall Study | COMPLETED | Benralizumab 30 mg | 497 | |
| Overall Study | COMPLETED | Benralizumab 100 mg | 492 | |
| Overall Study | COMPLETED | Placebo | 491 | |
| Overall Study | NOT COMPLETED | Benralizumab 30 mg | 57 | |
| Overall Study | NOT COMPLETED | Benralizumab 100 mg | 60 | |
| Overall Study | NOT COMPLETED | Placebo | 59 |
Source ClinicalTrials.gov
Adverse events789
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Benralizumab 30 mg | 17 | 554 | 19 |
| other | Constipation | Gastrointestinal disorders | Benralizumab 100 mg | 19 | 552 | 19 |
| other | Constipation | Gastrointestinal disorders | Placebo | 15 | 550 | 17 |
| other | Diarrhoea | Gastrointestinal disorders | Benralizumab 30 mg | 17 | 554 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Benralizumab 100 mg | 15 | 552 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 550 | 7 |
| other | Nausea | Gastrointestinal disorders | Benralizumab 30 mg | 13 | 554 | 17 |
| other | Nausea | Gastrointestinal disorders | Benralizumab 100 mg | 18 | 552 | 22 |
| other | Nausea | Gastrointestinal disorders | Placebo | 13 | 550 | 15 |
| other | Oedema peripheral | General disorders | Benralizumab 30 mg | 11 | 554 | 13 |
1 to 10 of 789Source ClinicalTrials.gov
See all 789 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab 30 mg | 15 | 554 |
| Total, all-cause mortality | Benralizumab 100 mg | 11 | 552 |
| Total, all-cause mortality | Placebo | 13 | 550 |
| Total, other adverse events | Benralizumab 30 mg | 293 | 554 |
| Total, other adverse events | Benralizumab 100 mg | 318 | 552 |
| Total, other adverse events | Placebo | 282 | 550 |
| Total, serious adverse events | Benralizumab 30 mg | 151 | 554 |
| Total, serious adverse events | Benralizumab 100 mg | 177 | 552 |
| Total, serious adverse events | Placebo | 176 | 550 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02138916
GET https://conductscience.org/api/trials/v1/NCT02138916/results?page=2