Trial · NCT01928771

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

NCT01928771, Phase 3, Completed, AstraZeneca; results first posted 2017-05-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma. Trials, record NCT01928771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01928771

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT number: NCT01928771
Status: Completed
Phases: Phase 3
Enrollment: 2,681 participants, actual
Lead sponsor: AstraZeneca
Conditions: Asthma
Interventions: Benralizumab, Placebo
First posted: 2013-08-27
Last updated: 2017-05-03
Results first posted: 2017-05-03

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 48.	The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
Secondary	Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL	Immediately following the first administration of study drug through Study Week 48.	The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
Secondary	Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations	Immediately following the first administration of study drug through Study Week 48.	The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)
Secondary	Number of Patients With >=1 Asthma Exacerbations	Immediately following the first administration of study drug through Study Week 48.
Secondary	Time to First Asthma Exacerbation	Immediately following the first administration of study drug through Study Week 48.
Secondary	Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 48.
Secondary	Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 48.
Secondary	Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 48.	Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Secondary	Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 48.	Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Secondary	Change in Asthma Rescue Medication	Immediately following the first administration of study drug through Study Week 48.	Change from baseline to week 48 in number of rescue medication use (puffs/day)

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \>=300/uL	events/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \<300/uL	events/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \>=300/uL	events/year	LEAST_SQUARES_MEAN
SECONDARY	Number of Patients With >=1 Asthma Exacerbations	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \>=300/uL	Participants	NUMBER
SECONDARY	Time to First Asthma Exacerbation	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \>=300/uL	Days	MEDIAN
SECONDARY	Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinopiles \>=300/uL	Liter	MEAN
SECONDARY	Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinopiles \<300/uL	Liter	MEAN
SECONDARY	Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \>=300/uL	Scores on a scale	MEAN
SECONDARY	Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \<300/uL	Scores on a scale	MEAN
SECONDARY	Change in Asthma Rescue Medication	Immediately following the first administration of study drug through Study Week 48.	Full analysis set, Baseline eosinophils \>=300/uL	Puffs/day	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group140

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

Outcome	Group	Value	Spread	Units
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL	Benralizumab 30 mg q.4 Weeks	0.73	95% Confidence Interval 0.60 to 0.89	events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL	Benralizumab 30 mg q.8 Weeks	0.65	95% Confidence Interval 0.53 to 0.80	events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL	Placebo	1.33	95% Confidence Interval 1.12 to 1.58	events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL	Benralizumab 30 mg q.4 Weeks	0.85	95% Confidence Interval 0.65 to 1.11	events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL	Benralizumab 30 mg q.8 Weeks	1.00	95% Confidence Interval 0.78 to 1.28	events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL	Placebo	1.21	95% Confidence Interval 0.96 to 1.52	events/year
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations	Benralizumab 30 mg q.4 Weeks	0.11	95% Confidence Interval 0.07 to 0.16	events/year
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations	Benralizumab 30 mg q.8 Weeks	0.06	95% Confidence Interval 0.04 to 0.11	events/year
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations	Placebo	0.18	95% Confidence Interval 0.13 to 0.25	events/year
Number of Patients With >=1 Asthma Exacerbations	Benralizumab 30 mg q.4 Weeks	100	84.227	Participants

1 to 10 of 140Source ClinicalTrials.gov

See all 140 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Benralizumab 30 mg q.4 Weeks	400
Overall Study	STARTED	Benralizumab 30 mg q.8 Weeks	398
Overall Study	STARTED	Placebo	407
Overall Study	Received Treatment	Benralizumab 30 mg q.4 Weeks	399
Overall Study	Received Treatment	Benralizumab 30 mg q.8 Weeks	398
Overall Study	Received Treatment	Placebo	407
Overall Study	COMPLETED	Benralizumab 30 mg q.4 Weeks	354
Overall Study	COMPLETED	Benralizumab 30 mg q.8 Weeks	358
Overall Study	COMPLETED	Placebo	367
Overall Study	NOT COMPLETED	Benralizumab 30 mg q.4 Weeks	46

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events330

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	Nausea	Gastrointestinal disorders	Benralizumab 30 mg q.4 Weeks	8	403	12
other	Nausea	Gastrointestinal disorders	Benralizumab 30 mg q.8 Weeks	12	394	14
other	Nausea	Gastrointestinal disorders	Placebo	8	407	9
other	Pyrexia	General disorders	Benralizumab 30 mg q.4 Weeks	16	403	21
other	Pyrexia	General disorders	Benralizumab 30 mg q.8 Weeks	12	394	19
other	Pyrexia	General disorders	Placebo	8	407	8
other	Acute sinusitis	Infections and infestations	Benralizumab 30 mg q.4 Weeks	10	403	11
other	Acute sinusitis	Infections and infestations	Benralizumab 30 mg q.8 Weeks	13	394	14
other	Acute sinusitis	Infections and infestations	Placebo	11	407	15
other	Bronchitis	Infections and infestations	Benralizumab 30 mg q.4 Weeks	27	403	28

1 to 10 of 330Source ClinicalTrials.gov

See all 330 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Benralizumab 30 mg q.4 Weeks
Total, all-cause mortality	Benralizumab 30 mg q.8 Weeks
Total, all-cause mortality	Placebo
Total, other adverse events	Benralizumab 30 mg q.4 Weeks	214	403
Total, other adverse events	Benralizumab 30 mg q.8 Weeks	199	394
Total, other adverse events	Placebo	219	407
Total, serious adverse events	Benralizumab 30 mg q.4 Weeks	51	403
Total, serious adverse events	Benralizumab 30 mg q.8 Weeks	54	394
Total, serious adverse events	Placebo	58	407

Source ClinicalTrials.gov

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27609408	DERIVED	PubMed
29409951	DERIVED	PubMed
30077185	DERIVED	PubMed
30139780	DERIVED	PubMed
30802500	DERIVED	PubMed
31626906	DERIVED	PubMed
31836949	DERIVED	PubMed
32334141	DERIVED	PubMed
35287231	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.

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/NCT01928771

GET https://conductscience.org/api/trials/v1/NCT01928771/registered?page=2

API reference For AI assistants