Trial · NCT02155660

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

NCT02155660, Phase 3, Completed, AstraZeneca; results first posted 2019-06-26

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 Exacerbation History. Trials, record NCT02155660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02155660

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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 Exacerbation History
NCT number: NCT02155660
Status: Completed
Phases: Phase 3
Enrollment: 2,255 participants, actual
Lead sponsor: AstraZeneca
Conditions: Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Interventions: Benralizumab Arm A, Benralizumab Arm B, Benralizumab Arm C, Placebo
First posted: 2014-06-04
Last updated: 2019-06-26
Results first posted: 2019-06-26

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	Immediately following the first IP dose through 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	Immediately following the first IP dose through 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 With 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 with 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 considering their experiences "today". The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD 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 considering their experiences "today". The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

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	Immediately following the first IP dose through week 56	Full analysis set, 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	Immediately following the first IP dose through week 56	Full analysis set, 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 With 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 outcomes

Results by group174

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	Benralizumab 10 mg	0.99	95% Confidence Interval 0.87 to 1.13	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	Benralizumab 30 mg	1.21	95% Confidence Interval 1.08 to 1.37	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	Benralizumab 100 mg	1.09	95% Confidence Interval 0.96 to 1.23	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL	Placebo	1.17	95% Confidence Interval 1.04 to 1.32	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	Benralizumab 10 mg	1.23	95% Confidence Interval 1.03 to 1.46	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	Benralizumab 30 mg	1.27	95% Confidence Interval 1.05 to 1.53	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	Benralizumab 100 mg	1.21	95% Confidence Interval 1.00 to 1.45	Exacerbations per year
Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL	Placebo	1.18	95% Confidence Interval 0.98 to 1.41	Exacerbations per year
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL	Benralizumab 10 mg	0.021	Standard Deviation 0.346	Liter
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL	Benralizumab 30 mg	0.011	Standard Deviation 0.289	Liter

1 to 10 of 174Source ClinicalTrials.gov

See all 174 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Benralizumab 10 mg	562
Overall Study	STARTED	Benralizumab 30 mg	562
Overall Study	STARTED	Benralizumab 100 mg	562
Overall Study	STARTED	Placebo	568
Overall Study	COMPLETED	Benralizumab 10 mg	504
Overall Study	COMPLETED	Benralizumab 30 mg	489
Overall Study	COMPLETED	Benralizumab 100 mg	502
Overall Study	COMPLETED	Placebo	507
Overall Study	NOT COMPLETED	Benralizumab 10 mg	58
Overall Study	NOT COMPLETED	Benralizumab 30 mg	73

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,132

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	Oedema peripheral	General disorders	Benra 10 mg	15	561	17
other	Oedema peripheral	General disorders	Benra 30 mg	9	563	9
other	Oedema peripheral	General disorders	Benra 100 mg	17	562	18
other	Oedema peripheral	General disorders	Placebo	9	568	10
other	Bronchitis	Infections and infestations	Benra 10 mg	66	561	94
other	Bronchitis	Infections and infestations	Benra 30 mg	70	563	100
other	Bronchitis	Infections and infestations	Benra 100 mg	63	562	87
other	Bronchitis	Infections and infestations	Placebo	66	568	88
other	Influenza	Infections and infestations	Benra 10 mg	11	561	11
other	Influenza	Infections and infestations	Benra 30 mg	20	563	22

1 to 10 of 1,132Source ClinicalTrials.gov

See all 1,132 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Benra 10 mg	17	561
Total, all-cause mortality	Benra 30 mg	21	563
Total, all-cause mortality	Benra 100 mg	17	562
Total, all-cause mortality	Placebo	19	568
Total, other adverse events	Benra 10 mg	251	561
Total, other adverse events	Benra 30 mg	233	563
Total, other adverse events	Benra 100 mg	238	562
Total, other adverse events	Placebo	260	568
Total, serious adverse events	Benra 10 mg	144	561
Total, serious adverse events	Benra 30 mg	177	563

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31112385	DERIVED	PubMed
31575508	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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