Trial · NCT02869438

A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation

NCT02869438, Phase 3, Completed, AstraZeneca; results first posted 2019-10-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation. Trials, record NCT02869438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02869438

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Trial

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

Title: A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
NCT number: NCT02869438
Status: Completed
Phases: Phase 3
Enrollment: 233 participants, actual
Lead sponsor: AstraZeneca
Conditions: Asthma
Interventions: Benralizumab, Placebo
First posted: 2016-08-17
Last updated: 2019-10-29
Other registries' IDs: eudract:2016-002094-36
Results first posted: 2019-10-07

Source ClinicalTrials.gov

Registered outcomes23

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

List	Outcome	Time frame	Description
Primary	Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	From first IP dose to Day 84	The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.
Primary	Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)	From first IP dose to Day 84	Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.
Secondary	Percent Change From Baseline to End of Treatment in Eosinophils Counts	From first IP dose to Day 84	Percent change from baseline to Day 84
Secondary	Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1	From first IP dose to Day 84	Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, Day 84. \[Note: Day 28, 56, 84 are presented in the Primary measure.\]
Secondary	Change From Baseline to Post Baseline for Pre-BD FVC	From first IP dose to Day 84	Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, and Day 84.
Secondary	Percentage of Pre-BD FEV1 Responder	From first IP dose to Day 84	Pre-BD FEV1 responder is defined as change from baseline in FEV1 \>=100 ml
Secondary	Change From Baseline in ACQ-6	From first IP dose to Day 84	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.
Secondary	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)	From first IP dose to Day 84	The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.
Secondary	Change From Baseline to End of Treatment in FeNO	From first IP dose to Day 84	Airway inflammation was evaluated via fractional exhaled nitric oxide (FeNO) measurement.
Secondary	Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients	From first IP dose to Day 84	Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.

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	Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	From first IP dose to Day 84	Full analysis set	Liter	MEAN
PRIMARY	Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)	From first IP dose to Day 84	Body plethysmography sub-study analysis set	Liter	MEAN
SECONDARY	Percent Change From Baseline to End of Treatment in Eosinophils Counts	From first IP dose to Day 84	Full analysis set	Percent change	MEAN
SECONDARY	Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1	From first IP dose to Day 84	Full analysis set	Liter	MEAN
SECONDARY	Change From Baseline to Post Baseline for Pre-BD FVC	From first IP dose to Day 84	Full analysis set	Liter	MEAN
SECONDARY	Percentage of Pre-BD FEV1 Responder	From first IP dose to Day 84	Full analysis set	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in ACQ-6	From first IP dose to Day 84	Full analysis set	Score on a scale	MEAN
SECONDARY	Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)	From first IP dose to Day 84	Full analysis set	Score on a scale	MEAN
SECONDARY	Change From Baseline to End of Treatment in FeNO	From first IP dose to Day 84	Full analysis set	ppb	MEAN
SECONDARY	Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients	From first IP dose to Day 84	Body plethysmography sub-study analysis set	Liter	MEAN

1 to 10 of 23Source ClinicalTrials.gov

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Results by group124

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	Benra 30 mg	Day 28	0.21	Standard Deviation 0.335	Liter
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	Placebo	Day 28	0.132	Standard Deviation 0.316	Liter
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	Benra 30 mg	Day 56	0.22	Standard Deviation 0.367	Liter
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	Placebo	Day 56	0.203	Standard Deviation 0.349	Liter
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	Benra 30 mg	Day 84	0.209	Standard Deviation 0.344	Liter
Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1	Placebo	Day 84	0.149	Standard Deviation 0.366	Liter
Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)	Benra 30 mg		-0.415	Standard Deviation 0.609	Liter
Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)	Placebo		-0.208	Standard Deviation 0.528	Liter
Percent Change From Baseline to End of Treatment in Eosinophils Counts	Benra 30 mg		-88.55	Full Range -100 to -12.5	Percent change
Percent Change From Baseline to End of Treatment in Eosinophils Counts	Placebo		11.55	Full Range -91.4 to 833.3	Percent change

1 to 10 of 124Source ClinicalTrials.gov

See all 124 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Benra 30 mg	118
Overall Study	STARTED	Placebo	115
Overall Study	COMPLETED	Benra 30 mg	115
Overall Study	COMPLETED	Placebo	113
Overall Study	NOT COMPLETED	Benra 30 mg	3
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events22

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	Bronchitis	Infections and infestations	Benra 30 mg	6	118	6
other	Bronchitis	Infections and infestations	Placebo	3	115	3
other	Nasopharyngitis	Infections and infestations	Benra 30 mg	8	118	9
other	Nasopharyngitis	Infections and infestations	Placebo	6	115	7
other	Upper respiratory tract infection	Infections and infestations	Benra 30 mg	6	118	7
other	Upper respiratory tract infection	Infections and infestations	Placebo	6	115	8
other	Asthma	Respiratory, thoracic and mediastinal disorders	Benra 30 mg	11	118	11
other	Asthma	Respiratory, thoracic and mediastinal disorders	Placebo	18	115	22
serious	Coronary artery disease	Cardiac disorders	Benra 30 mg	0	118	0
serious	Coronary artery disease	Cardiac disorders	Placebo	1	115	1

1 to 10 of 22Source ClinicalTrials.gov

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Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Benra 30 mg	0	118
Total, all-cause mortality	Placebo	0	115
Total, other adverse events	Benra 30 mg	28	118
Total, other adverse events	Placebo	30	115
Total, serious adverse events	Benra 30 mg	1	118
Total, serious adverse events	Placebo	7	115

Source ClinicalTrials.gov

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Benra 30 mg vs Placebo: deaths from any cause	Trial comparisons
Benra 30 mg vs Placebo: serious adverse events	Trial comparisons

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/NCT02869438

GET https://conductscience.org/api/trials/v1/NCT02869438/registered?page=2

API reference For AI assistants