Trial · NCT03470311
Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies
NCT03470311, Phase 3, Completed, McMaster University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies. Trials, record NCT03470311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03470311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies
- NCT number
- NCT03470311
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- McMaster University
- Conditions
- Severe Prednisone Dependent Eosinophilic Asthma
- Interventions
- Benralizumab, Placebo
- First posted
- 2018-03-19
- Last updated
- 2023-01-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sputum eosinophil percentage | Visit 1 (Week 2) and Visit 10 (Week 38) | Change in Percentage of sputum eosinophils (%) |
| Secondary | Blood eosinophils | Visit 1 (Week 2) and Visit 10 (Week 38) | Blood eosinophil level (x10\^9/L) |
| Secondary | Forced Expired Volume in 1 second (FEV1)(pre and post bronchodilator) | Visit 1 (Week 2) and Visit 10 (Week 38) | FEV1 in litres both pre and post bronchodilator |
| Secondary | ACQ-5 (Asthma Control Questionnaire) | Visit 1 (Week 2) and Visit 10 (Week 38) | Asthma Control Questionnaire score (mean answer of 5 questions on a 7-point scale (0=no impairment, 6= maximum impairment). |
| Secondary | Fraction of exhaled nitric oxide (FeNO) | Visit 1 (Week 2) and Visit 10 (Week 38) | Exhaled nitric oxide measurement in ppb |
| Secondary | Number of Exacerbations (defined as: ER visit/hospitalization requiring prednisone burst) | Visit 1 (Week 2) and Visit 10 (Week 38) | Worsening requiring increase in oral steroids/prednisone (30mg x 5 days) |
| Secondary | Sputum and blood ILC2 biology | Visit 1 (Week 2) and Visit 10 (Week 38) | Measurement of ILC2 biological cells in both blood and sputum |
| Secondary | Sputum autoimmune responses | Visit 1 (Week 2) and Visit 10 (Week 38) | Measurement of autoimmune markers in sputum: anti-eosinophil peroxidase (EPX) and anti-nuclear antibodies (ANA) - (See last reference PubMed ID: 28751233) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
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/NCT03470311
GET https://conductscience.org/api/trials/v1/NCT03470311/registered