Trial · NCT05006573
Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
NCT05006573, Phase 3, Terminated, AstraZeneca; results first posted 2025-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis. Trials, record NCT05006573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05006573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
- NCT number
- NCT05006573
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Interventions
- Benralizumab, Placebo to Benralizumab
- First posted
- 2021-08-16
- Last updated
- 2025-07-20
- Other registries' IDs
- eudract:2020-004068-24
- Results first posted
- 2025-07-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period. |
| Secondary | Time to First Exacerbation in the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Time to first NCFB exacerbation in the double-blind treatment period |
| Secondary | Change From Baseline in QoL-B-RSS Over the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in Quality of Life-Bronchiectasis-Respiratory Symptoms Scale over the double-blind treatment period. QoL-B-RSS scores range from 0 to 100, with higher scores indicative of better health-related quality of life. |
| Secondary | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in pre-dose pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) over the double-blind treatment period |
| Secondary | Change From Baseline in LCQ Total Score Over the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in Leicester Cough Questionnaire (LCQ) total score over the double-blind treatment period. LCQ total scores range from 3 to 21. Higher scores indicate better quality of life. |
| Secondary | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Physical Functioning Scale. QoL-B Physical Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life. |
| Secondary | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Role Functioning Scale. QoL-B Role Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life. |
| Secondary | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Emotional Functioning Scale. QoL-B Emotional Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life. |
| Secondary | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Social Functioning Scale. QoL-B Social Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life. |
| Secondary | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Vitality Scale. QoL-B Vitality Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Exacerbation in the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | days | MEDIAN |
| SECONDARY | Change From Baseline in QoL-B-RSS Over the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | L | MEAN |
| SECONDARY | Change From Baseline in LCQ Total Score Over the Double-blind Period | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale | through Double-blind period, at least 28 weeks and up to 52 weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of Investigational Product are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | score on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group504
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | Benralizumab 30 mg | 1.44 | 95% Confidence Interval 1.05 to 1.97 | exacerbations per year | |
| Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period | Placebo | 1.27 | 95% Confidence Interval 0.89 to 1.80 | exacerbations per year | |
| Time to First Exacerbation in the Double-blind Treatment Period | Benralizumab 30 mg | 233 | 95% Confidence Interval 118 to NA | days | |
| Time to First Exacerbation in the Double-blind Treatment Period | Placebo | 316 | 95% Confidence Interval 141 to NA | days | |
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | Benralizumab 30 mg | Week 2 | 6.6 | Standard Deviation 12.57 | score on a scale |
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | Placebo | Week 2 | 3.1 | Standard Deviation 11.65 | score on a scale |
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | Benralizumab 30 mg | Week 4 | 5.8 | Standard Deviation 12.53 | score on a scale |
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | Placebo | Week 4 | -1.5 | Standard Deviation 12.49 | score on a scale |
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | Benralizumab 30 mg | Week 6 | 6.8 | Standard Deviation 14.39 | score on a scale |
| Change From Baseline in QoL-B-RSS Over the Double-blind Period | Placebo | Week 6 | 0.7 | Standard Deviation 10.94 | score on a scale |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Benralizumab 30 mg | 54 | |
| Double-blind Treatment Period | STARTED | Placebo | 45 | |
| Double-blind Treatment Period | Treated | Benralizumab 30 mg | 54 | |
| Double-blind Treatment Period | Treated | Placebo | 45 | |
| Double-blind Treatment Period | COMPLETED | Benralizumab 30 mg | 42 | |
| Double-blind Treatment Period | COMPLETED | Placebo | 42 | |
| Double-blind Treatment Period | NOT COMPLETED | Benralizumab 30 mg | 12 | |
| Double-blind Treatment Period | NOT COMPLETED | Placebo | 3 | |
| Open-label Extension Period | STARTED | Benralizumab 30 mg | 38 | |
| Open-label Extension Period | STARTED | Placebo | 40 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events92
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 | Back pain | Musculoskeletal and connective tissue disorders | Benra 30 mg - DB | 4 | 54 | 4 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo - DB | 2 | 45 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Benra 30 mg - OLE | 0 | 38 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo Swithed to Benra 30 mg - OLE | 1 | 40 | 1 |
| other | Headache | Nervous system disorders | Benra 30 mg - DB | 5 | 54 | 5 |
| other | Headache | Nervous system disorders | Placebo - DB | 5 | 45 | 7 |
| other | Headache | Nervous system disorders | Benra 30 mg - OLE | 0 | 38 | 0 |
| other | Headache | Nervous system disorders | Placebo Swithed to Benra 30 mg - OLE | 2 | 40 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Benra 30 mg - DB | 3 | 54 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo - DB | 0 | 45 | 0 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg - DB | 0 | 54 |
| Total, all-cause mortality | Placebo - DB | 0 | 45 |
| Total, all-cause mortality | Benra 30 mg - OLE | 0 | 38 |
| Total, all-cause mortality | Placebo Swithed to Benra 30 mg - OLE | 0 | 40 |
| Total, other adverse events | Benra 30 mg - DB | 33 | 54 |
| Total, other adverse events | Placebo - DB | 18 | 45 |
| Total, other adverse events | Benra 30 mg - OLE | 9 | 38 |
| Total, other adverse events | Placebo Swithed to Benra 30 mg - OLE | 9 | 40 |
| Total, serious adverse events | Benra 30 mg - DB | 10 | 54 |
| Total, serious adverse events | Placebo - DB | 3 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT05006573
GET https://conductscience.org/api/trials/v1/NCT05006573/results?page=2