Trial · NCT02075255
Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
NCT02075255, Phase 3, Completed, AstraZeneca; results first posted 2017-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy. Trials, record NCT02075255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02075255
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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 to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
- NCT number
- NCT02075255
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 220 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Placebo, Benralizumab
- First posted
- 2014-03-03
- Last updated
- 2018-06-08
- Results first posted
- 2017-10-17
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control | Week 28 | Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}\*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event. |
| Secondary | Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Week 28 | Number and percentage of patients in different categories of percent reduction from baseline in final OCS dose. |
| Secondary | Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uL | Week 28 | Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}\*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event. |
| Secondary | The Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control | Week 28 | Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}\*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event. |
| Secondary | The Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control | Week 28 | Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}\*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event. |
| Secondary | The Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control. | Week 28 | Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event. |
| Secondary | The Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma Control | Week 28 | Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event. |
| Secondary | Number and Percentage of Patients With ≥1 Asthma Exacerbation | Immediately following the randomisation through Study Week 28 | Number and percentage of patients with at least one post randomisation asthma exacerbation. |
| Secondary | Time to the First Asthma Exacerbation | The time from randomisation to the date of first asthma exacerbation over 28 weeks | Time to the first occurrence of asthma exacerbation post randomisation |
| Secondary | Time to the First Asthma Exacerbation Requiring Hospitalization or ER Visit | The time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks. | Time to the first exacerbation requiring hospitalization or ER visit post randomisation |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control | Week 28 | Full analysis set | Percent | MEDIAN |
| SECONDARY | Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Week 28 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uL | Week 28 | Full analysis set, baseline blood eosinophil \>=300/uL | Percent | MEDIAN |
| SECONDARY | The Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control | Week 28 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control | Week 28 | Full analysis set, eligible for 100% reduction (ie, patients with baseline OCS dose \<= 12.5 mg) | Participants | NUMBER |
| SECONDARY | The Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control. | Week 28 | Full analysis set | Participants | NUMBER |
| SECONDARY | The Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma Control | Week 28 | Full analysis set | Participants | NUMBER |
| SECONDARY | Number and Percentage of Patients With ≥1 Asthma Exacerbation | Immediately following the randomisation through Study Week 28 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to the First Asthma Exacerbation | The time from randomisation to the date of first asthma exacerbation over 28 weeks | Full analysis set | Days | MEDIAN |
| SECONDARY | Time to the First Asthma Exacerbation Requiring Hospitalization or ER Visit | The time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks. | Full analysis set | Days | MEDIAN |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group157
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control | Benralizumab 30 mg q.4 Weeks | 75.00 | 95% Confidence Interval 50.00 to 83.30 | Percent | |
| Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control | Benralizumab 30 mg q.8 Weeks | 75.00 | 95% Confidence Interval 60.00 to 87.50 | Percent | |
| Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control | Placebo | 25.00 | 95% Confidence Interval 0.00 to 33.30 | Percent | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Benralizumab 30 mg q.4 Weeks | >=90% reduction | 24 | Participants | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Benralizumab 30 mg q.8 Weeks | >=90% reduction | 27 | Participants | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Placebo | >=90% reduction | 9 | Participants | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Benralizumab 30 mg q.4 Weeks | >=75% reduction | 38 | Participants | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Benralizumab 30 mg q.8 Weeks | >=75% reduction | 37 | Participants | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Placebo | >=75% reduction | 15 | Participants | |
| Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control | Benralizumab 30 mg q.4 Weeks | >=50% reduction | 48 | Participants |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab 30 mg q.4 Weeks | 72 | |
| Overall Study | STARTED | Benralizumab 30 mg q.8 Weeks | 73 | |
| Overall Study | STARTED | Placebo | 75 | |
| Overall Study | COMPLETED | Benralizumab 30 mg q.4 Weeks | 68 | |
| Overall Study | COMPLETED | Benralizumab 30 mg q.8 Weeks | 69 | |
| Overall Study | COMPLETED | Placebo | 72 | |
| Overall Study | NOT COMPLETED | Benralizumab 30 mg q.4 Weeks | 4 | |
| Overall Study | NOT COMPLETED | Benralizumab 30 mg q.8 Weeks | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events117
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 | Vertigo | Ear and labyrinth disorders | Benra 30 mg q.4 Weeks | 1 | 72 | 5 |
| other | Vertigo | Ear and labyrinth disorders | Benra 30 mg q.8 Weeks | 3 | 73 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 2 | 75 | 2 |
| other | Nausea | Gastrointestinal disorders | Benra 30 mg q.4 Weeks | 1 | 72 | 1 |
| other | Nausea | Gastrointestinal disorders | Benra 30 mg q.8 Weeks | 0 | 73 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 75 | 3 |
| other | Bronchitis | Infections and infestations | Benra 30 mg q.4 Weeks | 5 | 72 | 7 |
| other | Bronchitis | Infections and infestations | Benra 30 mg q.8 Weeks | 8 | 73 | 10 |
| other | Bronchitis | Infections and infestations | Placebo | 12 | 75 | 13 |
| other | Influenza | Infections and infestations | Benra 30 mg q.4 Weeks | 3 | 72 | 3 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg q.4 Weeks | ||
| Total, all-cause mortality | Benra 30 mg q.8 Weeks | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Benra 30 mg q.4 Weeks | 34 | 72 |
| Total, other adverse events | Benra 30 mg q.8 Weeks | 34 | 73 |
| Total, other adverse events | Placebo | 49 | 75 |
| Total, serious adverse events | Benra 30 mg q.4 Weeks | 7 | 72 |
| Total, serious adverse events | Benra 30 mg q.8 Weeks | 7 | 73 |
| Total, serious adverse events | Placebo | 14 | 75 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT02075255
GET https://conductscience.org/api/trials/v1/NCT02075255/registered?page=2