Trial · NCT03557307
Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
NCT03557307, Phase 3, Completed, AstraZeneca; results first posted 2022-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma. Trials, record NCT03557307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03557307
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
- NCT number
- NCT03557307
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 598 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab
- First posted
- 2018-06-15
- Last updated
- 2023-06-06
- Results first posted
- 2022-06-28
- Limitations and caveats
- During COVID-19 pandemic, for ongoing patients, patient dosing, and scheduled visits are inevitably impacted, but the primary endpoint was not impacted.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients Who Achieve 100% Reduction in Daily OCS Dose | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma |
| Primary | Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma |
| Secondary | Patients Who Achieve a Daily OCS of ≤5mg | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma |
| Secondary | Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma |
| Secondary | Change From Baseline in Average Daily OCS Dose (mg) | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Change from baseline in average daily OCS dose (mg) from start of OCS reduction to end of the OCS reduction phase |
| Other | Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Patients who achieve 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma |
| Other | Patients Who Achieve a Daily OCS Dose of ≤5 mg at the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma |
| Other | Patients Who Achieve ≥90%, ≥75%, ≥50% or >0% OCS Reduction From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Patients who achieve a ≥90%, ≥75%, and ≥50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma |
| Other | Change in Daily OCS Dose (mg) From Main Study Baseline to the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Change in average daily OCS dose (mg) from main study baseline to the end of the long term follow up substudy |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients Who Achieve 100% Reduction in Daily OCS Dose | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Full analysis set - All enrolled patients who received at least one dose of benralizumab are included in the FAS, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | All enrolled patients who received at least one dose of benralizumab are included in the FAS, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patients Who Achieve a Daily OCS of ≤5mg | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Full analysis set - All enrolled patients who received at least one dose of benralizumab are included in the FAS, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Full analysis set - All enrolled patients who received at least one dose of benralizumab are included in the FAS, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Average Daily OCS Dose (mg) | Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.) | Full analysis set - All enrolled patients who received at least one dose of benralizumab are included in the FAS, irrespective of their protocol adherence and continued participation in the study. | mg | MEAN |
| OTHER_PRE_SPECIFIED | Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Long term follow up analysis set - All patients who enrolled in Long Term Follow Up substudy | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Patients Who Achieve a Daily OCS Dose of ≤5 mg at the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Long Term Follow Up analysis set - All patients who enrolled in Long Term Follow Up substudy | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Patients Who Achieve ≥90%, ≥75%, ≥50% or >0% OCS Reduction From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Long Term Follow Up analysis set - All patients who enrolled in Long Term Follow Up substudy | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Daily OCS Dose (mg) From Main Study Baseline to the End of the Long Term Follow up Substudy | from main study baseline to the end of the long term follow up substudy, an average of approximate 922 days. | Long Term Follow Up analysis set - All patients who enrolled in Long Term Follow Up substudy | mg | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients Who Achieve 100% Reduction in Daily OCS Dose | Benra 30 mg | 376 | Participants | ||
| Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg | Benra 30 mg | 490 | Participants | ||
| Patients Who Achieve a Daily OCS of ≤5mg | Benra 30 mg | 547 | Participants | ||
| Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose | Benra 30 mg | ≥90% reduction | 383 | Participants | |
| Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose | Benra 30 mg | ≥75% reduction | 412 | Participants | |
| Patients Who Achieve a ≥90%, ≥75%, and ≥50% Reduction in Daily OCS Dose | Benra 30 mg | ≥50% reduction | 489 | Participants | |
| Change From Baseline in Average Daily OCS Dose (mg) | Benra 30 mg | -8.50 | 95% Confidence Interval -9.10 to -7.90 | mg | |
| Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | Asthma Treatment as Per Healthcare Provider Discretion | 138 | Participants | ||
| Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | >=50% Any Biologic | 60 | Participants | ||
| Patients Who Achieve 100% Reduction in Daily OCS Dose From Main Study Baseline OCS Dose to the End of the Long Term Follow up Substudy | >=50% Benra | 54 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: To End of OCS Reduction Phase | STARTED | Benra 30 mg | 598 | |
| Period 1: To End of OCS Reduction Phase | COMPLETED | Benra 30 mg | 563 | |
| Period 1: To End of OCS Reduction Phase | NOT COMPLETED | Benra 30 mg | 35 | |
| Period 2: Maintenance Phase | STARTED | Benra 30 mg | 563 | |
| Period 2: Maintenance Phase | COMPLETED | Benra 30 mg | 536 | |
| Period 2: Maintenance Phase | NOT COMPLETED | Benra 30 mg | 27 | |
| Period 3: Long Term Follow up Substudy | STARTED | Benra 30 mg | 195 | |
| Period 3: Long Term Follow up Substudy | Asthma Treatment as Per Healthcare Provider Discretion | Benra 30 mg | 195 | |
| Period 3: Long Term Follow up Substudy | >=50% Any Biologic | Benra 30 mg | 78 | |
| Period 3: Long Term Follow up Substudy | >=50% Benra | Benra 30 mg | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events316
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 | Influenza like illness | General disorders | Benra 30 mg | 33 | 598 | 34 |
| other | Influenza like illness | General disorders | Asthma Treatment as Per Healthcare Provider Discretion | 0 | 195 | 0 |
| other | Influenza like illness | General disorders | >=50% Any Biologic | 0 | 78 | 0 |
| other | Influenza like illness | General disorders | >=50% Benra | 0 | 69 | 0 |
| other | Nasopharyngitis | Infections and infestations | Benra 30 mg | 64 | 598 | 92 |
| other | Nasopharyngitis | Infections and infestations | Asthma Treatment as Per Healthcare Provider Discretion | 0 | 195 | 0 |
| other | Nasopharyngitis | Infections and infestations | >=50% Any Biologic | 0 | 78 | 0 |
| other | Nasopharyngitis | Infections and infestations | >=50% Benra | 0 | 69 | 0 |
| other | Sinusitis | Infections and infestations | Benra 30 mg | 19 | 598 | 22 |
| other | Sinusitis | Infections and infestations | Asthma Treatment as Per Healthcare Provider Discretion | 0 | 195 | 0 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg | 5 | 598 |
| Total, all-cause mortality | Asthma Treatment as Per Healthcare Provider Discretion | 0 | 195 |
| Total, all-cause mortality | >=50% Any Biologic | 0 | 78 |
| Total, all-cause mortality | >=50% Benra | 0 | 69 |
| Total, other adverse events | Benra 30 mg | 181 | 598 |
| Total, other adverse events | Asthma Treatment as Per Healthcare Provider Discretion | 0 | 195 |
| Total, other adverse events | >=50% Any Biologic | 0 | 78 |
| Total, other adverse events | >=50% Benra | 0 | 69 |
| Total, serious adverse events | Benra 30 mg | 89 | 598 |
| Total, serious adverse events | Asthma Treatment as Per Healthcare Provider Discretion | 0 | 195 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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/NCT03557307
GET https://conductscience.org/api/trials/v1/NCT03557307/results?page=2