Trial · NCT02322775
Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
NCT02322775, Phase 3, Completed, AstraZeneca; results first posted 2017-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma. Trials, record NCT02322775. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02322775
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
- NCT number
- NCT02322775
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 211 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Placebo
- First posted
- 2014-12-23
- Last updated
- 2017-08-15
- Other registries' IDs
- eudract:2014-004427-40
- Results first posted
- 2017-02-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Baseline, Week 4, Week 8 and Week 12 | The FEV1 (L) change from baseline are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) analysis with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline pre-bronchodilator FEV1 (L) as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The changes from baseline of weekly average of morning PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit, region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline morning PEF (L/min) as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The changes from baseline of weekly average of evening PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit, region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline evening PEF (L/min) as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Change From Baseline in Total Asthma Symptom Score at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | Asthma symptoms were recorded by the patient each morning and evening in the asthma daily diary. Symptoms were recorded using a scale of 0-3, where 0 indicates no asthma symptoms. The daily asthma symptom total score was calculated by taking the sum of the daytime score recorded in the evening and the nighttime score recorded the following morning. The weekly total asthma score was averaged from the daily scores over a 7 day period, with score ranging from 0 to 6, where 0 indicates no asthma symptoms. The changes from baseline of weekly total asthma score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit, region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline total asthma score as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The number of rescue medication inhalations and nebulizer treatments taken were recorded by the patient in the asthma daily diary twice daily. The number of inhalations (puffs) per day was calculated as \[number of night inhaler puffs\] + 2 x \[number of night nebulizer times\] + number of day inhaler puffs + 2 x \[number of day nebulizer times\]. The changes from baseline in weekly total asthma rescue medication use (puffs) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit, region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline total asthma rescue medication use (puffs) as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | Nocturnal awakenings due to asthma symptoms and requiring rescue medication use was recorded by the patient in the asthma daily diary each morning. Proportion of nights with nocturnal awakenings was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data for awakening due to asthma. The outcome variable for proportion of nights with nocturnal awakenings was the change from baseline at Week 12 in weekly proportion of nights with nocturnal awakenings. The changes are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit, region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline proportion of nights with nocturnal awakenings as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Change From Baseline in Mean ACQ-6 Score at Week 12 | Baseline, Week 4, Week 8 and Week 12 | The asthma control questionnaire, ACQ-6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. The changes from baseline of ACQ-6 score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment\*visit interaction as fixed effects and baseline ACQ-6 score as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Asthma Exacerbations | Up to Week 12 | An asthma exacerbation was defined as a worsening of asthma that led to use of systemic corticosteroids for at least 3 days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids) or an emergency room or urgent care visit (defined as evaluation and treatment for \<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above) or an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. Number of patients experiencing an event included in the definition of asthma exacerbation was presented. |
| Secondary | Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12 | Baseline and Week 12 | The asthma quality of life questionnaire for 12 years and older, AQLQ(S)+12, consists of 32 questions; all assessed on a 7-point scale from 7 to 1, where 7 represents no impairment and 1 represents severe impairment. The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains. The overall score is calculated as the mean response to all questions. The changes from baseline of AQLQ(S)+12 score are compared between benralizumab 30 mg Q4W and placebo by using the analyse of covariance (ANCOVA) with baseline blood eosinophil count (≥300 cells/μL or \<300 cells/μL) and region (Europe or North America) as fixed effects and baseline AQLQ(S)+12 score as a covariate. Changes at Week 12 were calculated based on patients with both baseline and Week 12. |
| Secondary | Serum Concentrations (ng/mL) | Baseline, Week 12 and Week 20 | Blood samples (processed to serum) for pharmacokinetic assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit. Serum concentrations of benralizumab were determined using a validated electrochemiluminescent (ECL) immunoassay. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Baseline, Week 4, Week 8 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Litre | MEAN |
| SECONDARY | Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | L/min | MEAN |
| SECONDARY | Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | L/min | MEAN |
| SECONDARY | Change From Baseline in Total Asthma Symptom Score at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Puffs per day | MEAN |
| SECONDARY | Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Proportion of nights | MEAN |
| SECONDARY | Change From Baseline in Mean ACQ-6 Score at Week 12 | Baseline, Week 4, Week 8 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Scores on a scale | MEAN |
| SECONDARY | Asthma Exacerbations | Up to Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Patients per number of exacerbations | NUMBER |
| SECONDARY | Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12 | Baseline and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Scores on a scale | MEAN |
| SECONDARY | Serum Concentrations (ng/mL) | Baseline, Week 12 and Week 20 | The pharmacokinetic (PK) analysis set comprised all patients who received benralizumab and from whom PK blood samples were obtained are assumed not to be affected by factors such as protocol violations. Those patients who had at least 1 quantifiable serum PK observation post first dose were included in the PK analysis dataset. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Benralizumab 30 mg Q4W | Baseline | 2.248 | Standard Deviation 0.6062 | Litre |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Placebo | Baseline | 2.246 | Standard Deviation 0.7677 | Litre |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Benralizumab 30 mg Q4W | Week 12 | 2.310 | Standard Deviation 0.6702 | Litre |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Placebo | Week 12 | 2.261 | Standard Deviation 0.7959 | Litre |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Benralizumab 30 mg Q4W | Change from baseline at Week 12 | 0.057 | Standard Deviation 0.2734 | Litre |
| Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Placebo | Change from baseline at Week 12 | -0.016 | Standard Deviation 0.2350 | Litre |
| Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Benralizumab 30 mg Q4W | Baseline | 307.413 | Standard Deviation 95.9467 | L/min |
| Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Placebo | Baseline | 308.226 | Standard Deviation 113.5895 | L/min |
| Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Benralizumab 30 mg Q4W | Week 12 | 311.041 | Standard Deviation 101.8169 | L/min |
| Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Placebo | Week 12 | 304.037 | Standard Deviation 113.2538 | L/min |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab 30 mg Q4W | 106 | |
| Overall Study | STARTED | Placebo | 105 | |
| Overall Study | COMPLETED | Benralizumab 30 mg Q4W | 101 | |
| Overall Study | COMPLETED | Placebo | 99 | |
| Overall Study | NOT COMPLETED | Benralizumab 30 mg Q4W | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events16
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 | Nasopharyngitis | Infections and infestations | Benralizumab 30 mg Q4W | 8 | 106 | 8 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 8 | 105 | 9 |
| other | Upper respiratory tract infection | Infections and infestations | Benralizumab 30 mg Q4W | 5 | 106 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 5 | 105 | 5 |
| other | Headache | Nervous system disorders | Benralizumab 30 mg Q4W | 4 | 106 | 7 |
| other | Headache | Nervous system disorders | Placebo | 1 | 105 | 1 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Benralizumab 30 mg Q4W | 4 | 106 | 4 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 3 | 105 | 3 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Benralizumab 30 mg Q4W | 1 | 106 | 1 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Placebo | 0 | 105 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab 30 mg Q4W | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Benralizumab 30 mg Q4W | 19 | 106 |
| Total, other adverse events | Placebo | 14 | 105 |
| Total, serious adverse events | Benralizumab 30 mg Q4W | 2 | 106 |
| Total, serious adverse events | Placebo | 2 | 105 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28545978 | BACKGROUND |
Source 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Benralizumab 30 mg Q4W vs Placebo: serious adverse events |
Source 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.
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/NCT02322775
GET https://conductscience.org/api/trials/v1/NCT02322775/results?page=2