Trial · NCT01947946
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT01947946, Phase 3, Terminated, AstraZeneca; results first posted 2015-11-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma. Trials, record NCT01947946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01947946
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
- NCT number
- NCT01947946
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 13 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Asthma
- Interventions
- Benralizumab, Placebo
- First posted
- 2013-09-23
- Last updated
- 2015-11-24
- Results first posted
- 2015-11-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Asthma Exacerbations Over 48 Weeks Treatment | 48 weeks treatment | The number of asthma exacerbations over 48 weeks treatment will be counted |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Asthma Exacerbations Over 48 Weeks Treatment | 48 weeks treatment | Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Number of events | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Asthma Exacerbations Over 48 Weeks Treatment | Benra 30 mg q.4 Weeks | 0 | Number of events | ||
| Asthma Exacerbations Over 48 Weeks Treatment | Benra 30 Mg-Placebo q.8 Weeks | 0 | Number of events | ||
| Asthma Exacerbations Over 48 Weeks Treatment | Placebo | 0 | Number of events |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benra 30 mg q.4 Weeks | 3 | |
| Overall Study | STARTED | Benra 30 Mg-Placebo q.8 Weeks | 5 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Benra 30 mg q.4 Weeks | 0 | |
| Overall Study | COMPLETED | Benra 30 Mg-Placebo q.8 Weeks | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Benra 30 mg q.4 Weeks | 3 | |
| Overall Study | NOT COMPLETED | Benra 30 Mg-Placebo q.8 Weeks | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events3
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 | Prolonged expiration | Respiratory, thoracic and mediastinal disorders | Benra 30 mg q.4 Weeks | 0 | 3 | 0 |
| other | Prolonged expiration | Respiratory, thoracic and mediastinal disorders | Benra 30 Mg-Placebo q.8 Weeks | 0 | 5 | 0 |
| other | Prolonged expiration | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse 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-Placebo q.8 Weeks | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Benra 30 mg q.4 Weeks | 0 | 3 |
| Total, other adverse events | Benra 30 Mg-Placebo q.8 Weeks | 0 | 5 |
| Total, other adverse events | Placebo | 1 | 5 |
| Total, serious adverse events | Benra 30 mg q.4 Weeks | 0 | 3 |
| Total, serious adverse events | Benra 30 Mg-Placebo q.8 Weeks | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 5 |
Source ClinicalTrials.gov
Papers0
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/NCT01947946
GET https://conductscience.org/api/trials/v1/NCT01947946/registered