Trial · NCT03186209
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
NCT03186209, Phase 3, Completed, AstraZeneca; results first posted 2024-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE). Trials, record NCT03186209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03186209
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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 Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
- NCT number
- NCT03186209
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 695 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Placebo
- First posted
- 2017-06-14
- Last updated
- 2024-04-24
- Other registries' IDs
- eudract:2017-000702-38
- Results first posted
- 2024-04-24
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups |
| Secondary | Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Change from baseline at Week 48 in Pre-bronchodilator FEV1 (L) |
| Secondary | Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Daytime and nighttime symptoms are reported using a response scale ranging from 0 to 3 where 0 indicates no asthma symptoms. The total asthma symptom score is the sum of the daytime and nighttime scores and ranges from 0 to 6; a decrease in score indicates symptom improvement. |
| Secondary | Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Change from baseline at week 48 in total rescue medication use (number of puffs/day) |
| Secondary | Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Change from baseline at week 48 in morning PEF |
| Secondary | Change From Baseline at Week 48 in Evening Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Change from baseline at week 48 in evening PEF |
| Secondary | Change From Baseline at Week 48 in the Proportion of Night Awakening Due to Asthma and Requiring Rescue Medication for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Change from baseline at Week 48 in proportion of night awakening due to asthma and requiring rescue medication |
| Secondary | Change From Baseline at Week 48 in Asthma Control Questionnaire 6 (ACQ-6) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | 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. |
| Secondary | Time to First Asthma Exacerbation for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Time to first asthma exacerbation over 48-week treatment period |
| Secondary | Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Number and percentage of patients with at least one exacerbation over 48-week treatment period |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | events/patient-year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Liter | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Puffs/day | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | L/min | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Evening Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | L/min | MEAN |
| SECONDARY | Change From Baseline at Week 48 in the Proportion of Night Awakening Due to Asthma and Requiring Rescue Medication for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Proportion of nights | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Asthma Control Questionnaire 6 (ACQ-6) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Scores on a scale | MEAN |
| SECONDARY | Time to First Asthma Exacerbation for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | Days | MEDIAN |
| SECONDARY | Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL | Benralizumab 30 mg | 0.49 | 95% Confidence Interval 0.33 to 0.72 | events/patient-year | |
| Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL | Placebo | 1.88 | 95% Confidence Interval 1.35 to 2.61 | events/patient-year | |
| Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Benralizumab 30 mg | 0.333 | Standard Deviation 0.4499 | Liter | |
| Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Placebo | 0.103 | Standard Deviation 0.4841 | Liter | |
| Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Benralizumab 30 mg | -1.07 | Standard Deviation 1.126 | Scores on a scale | |
| Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Placebo | -0.80 | Standard Deviation 1.129 | Scores on a scale | |
| Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Benralizumab 30 mg | -0.85 | Standard Deviation 1.865 | Puffs/day | |
| Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Placebo | -0.89 | Standard Deviation 2.213 | Puffs/day | |
| Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Benralizumab 30 mg | 54.194 | Standard Deviation 86.3963 | L/min | |
| Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Placebo | 12.995 | Standard Deviation 68.7947 | L/min |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab 30 mg | 348 | |
| Overall Study | STARTED | Placebo | 347 | |
| Overall Study | Dosed | Benralizumab 30 mg | 348 | |
| Overall Study | Dosed | Placebo | 347 | |
| Overall Study | COMPLETED | Benralizumab 30 mg | 331 | |
| Overall Study | COMPLETED | Placebo | 321 | |
| Overall Study | NOT COMPLETED | Benralizumab 30 mg | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 26 |
Source ClinicalTrials.gov
Adverse events162
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 | 18 | 348 | 22 |
| other | Pyrexia | General disorders | Placebo | 9 | 347 | 9 |
| other | Bronchitis | Infections and infestations | Benralizumab 30 mg | 11 | 348 | 15 |
| other | Bronchitis | Infections and infestations | Placebo | 27 | 347 | 40 |
| other | COVID-19 | Infections and infestations | Benralizumab 30 mg | 11 | 348 | 11 |
| other | COVID-19 | Infections and infestations | Placebo | 6 | 347 | 6 |
| other | Nasopharyngitis | Infections and infestations | Benralizumab 30 mg | 28 | 348 | 36 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 33 | 347 | 48 |
| other | Otitis media | Infections and infestations | Benralizumab 30 mg | 11 | 348 | 11 |
| other | Otitis media | Infections and infestations | Placebo | 8 | 347 | 9 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab 30 mg | 0 | 348 |
| Total, all-cause mortality | Placebo | 0 | 347 |
| Total, other adverse events | Benralizumab 30 mg | 194 | 348 |
| Total, other adverse events | Placebo | 194 | 347 |
| Total, serious adverse events | Benralizumab 30 mg | 44 | 348 |
| Total, serious adverse events | Placebo | 63 | 347 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Benralizumab 30 mg vs Placebo: Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | Trial comparisons |
| Benralizumab 30 mg vs Placebo: deaths from any cause | Trial comparisons |
| Benralizumab 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.
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/NCT03186209
GET https://conductscience.org/api/trials/v1/NCT03186209/results?page=2