Trial · NCT01914757

Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

NCT01914757, Phase 3, Completed, AstraZeneca; results first posted 2017-01-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist. Trials, record NCT01914757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01914757

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Trial

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

Title: Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
NCT number: NCT01914757
Status: Completed
Phases: Phase 3
Enrollment: 2,508 participants, actual
Lead sponsor: AstraZeneca
Conditions: Asthma
Interventions: Benralizumab, Placebo
First posted: 2013-08-02
Last updated: 2017-01-25
Results first posted: 2017-01-25

Source ClinicalTrials.gov

Registered outcomes23

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 Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	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 Patients With Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 56.	The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Secondary	Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.
Secondary	Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 56.
Secondary	Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint 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 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 56.	Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint 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 Use	Immediately following the first administration of study drug through Study Week 56.	Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
Secondary	Home Lung Function Assessments Based on PEF	Immediately following the first administration of study drug through Study Week 56.	Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow \[PEF\])
Secondary	Proportion of Nights With Awakening Due to Asthma	Immediately following the first administration of study drug through Study Week 56.	Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
Secondary	Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \<=0.75 indicates well-controlled asthma, scores between 0.75 to \<=1.5 indicate partly controlled asthma, and \>1.5 indicates not well controlled asthma.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

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 Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS.	Events/year	LEAST_SQUARES_MEAN
SECONDARY	Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS.	Events/year	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS	Liter	MEAN
SECONDARY	Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS	Liter	MEAN
SECONDARY	Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS	Scores on a scale	MEAN
SECONDARY	Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \<300/uL, High-dose ICS	Scores on a scale	MEAN
SECONDARY	Change in Asthma Rescue Medication Use	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS	Puffs per day	MEAN
SECONDARY	Home Lung Function Assessments Based on PEF	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS	L/min	MEAN
SECONDARY	Proportion of Nights With Awakening Due to Asthma	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS	Proportion of nights	MEAN
SECONDARY	Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL	Immediately following the first administration of study drug through Study Week 56.	Full analysis set, Baseline eosinophils \>=300/uL, High-dose ICS	Scores on a scale	MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 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 Patients With Baseline Eosinophils >=300/uL	Benralizumab 30 mg q.4 Weeks	0.6	95% Confidence Interval 0.48 to 0.74	Events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL	Benralizumab 30 mg q.8 Weeks	0.66	95% Confidence Interval 0.54 to 0.82	Events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL	Placebo	0.93	95% Confidence Interval 0.77 to 1.12	Events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL	Benralizumab 30 mg q.4 Weeks	0.78	95% Confidence Interval 0.59 to 1.02	Events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL	Benralizumab 30 mg q.8 Weeks	0.73	95% Confidence Interval 0.55 to 0.95	Events/year
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL	Placebo	1.21	95% Confidence Interval 0.96 to 1.52	Events/year
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL	Benralizumab 30 mg q.4 Weeks	0.34	Standard Deviation 0.469	Liter
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL	Benralizumab 30 mg q.8 Weeks	0.332	Standard Deviation 0.518	Liter
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL	Placebo	0.206	Standard Deviation 0.471	Liter
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL	Benralizumab 30 mg q.4 Weeks	0.221	Standard Deviation 0.441	Liter

1 to 10 of 140Source ClinicalTrials.gov

See all 140 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Benralizumab 30 mg q.4 Weeks	425
Overall Study	STARTED	Benralizumab 30 mg q.8 Weeks	441
Overall Study	STARTED	Placebo	440
Overall Study	COMPLETED	Benralizumab 30 mg q.4 Weeks	389
Overall Study	COMPLETED	Benralizumab 30 mg q.8 Weeks	390
Overall Study	COMPLETED	Placebo	402
Overall Study	NOT COMPLETED	Benralizumab 30 mg q.4 Weeks	36
Overall Study	NOT COMPLETED	Benralizumab 30 mg q.8 Weeks	51
Overall Study	NOT COMPLETED	Placebo	38

Source ClinicalTrials.gov

Adverse events345

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	Pyrexia	General disorders	Benralizumab 30 mg q.4 Weeks	16	438	20
other	Pyrexia	General disorders	Benralizumab 30 mg q.8 Weeks	13	428	13
other	Pyrexia	General disorders	Placebo	6	440	6
other	Acute sinusitis	Infections and infestations	Benralizumab 30 mg q.4 Weeks	6	438	6
other	Acute sinusitis	Infections and infestations	Benralizumab 30 mg q.8 Weeks	5	428	6
other	Acute sinusitis	Infections and infestations	Placebo	14	440	19
other	Bronchitis	Infections and infestations	Benralizumab 30 mg q.4 Weeks	40	438	51
other	Bronchitis	Infections and infestations	Benralizumab 30 mg q.8 Weeks	45	428	54
other	Bronchitis	Infections and infestations	Placebo	54	440	72
other	Influenza	Infections and infestations	Benralizumab 30 mg q.4 Weeks	24	438	27

1 to 10 of 345Source ClinicalTrials.gov

See all 345 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	244	438
Total, other adverse events	Benralizumab 30 mg q.8 Weeks	232	428
Total, other adverse events	Placebo	264	440
Total, serious adverse events	Benralizumab 30 mg q.4 Weeks	46	438
Total, serious adverse events	Benralizumab 30 mg q.8 Weeks	41	428
Total, serious adverse events	Placebo	61	440

Source ClinicalTrials.gov

Papers10

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27609406	DERIVED	PubMed
29128192	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.

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