Trial · NCT06288516
BenRalizumab Effect on Airway Remodeling in Severe asTHma
NCT06288516, Phase 4, Completed, Aristotle University Of Thessaloniki
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BenRalizumab Effect on Airway Remodeling in Severe asTHma. Trials, record NCT06288516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06288516
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BenRalizumab Effect on Airway Remodeling in Severe asTHma
- NCT number
- NCT06288516
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 36 participants, actual
- Lead sponsor
- Aristotle University Of Thessaloniki
- Conditions
- Asthma; Eosinophilic, Airway Remodeling
- Interventions
- Benralizumab 30 mg/ml
- First posted
- 2024-03-01
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in sub-basement membrane thickness | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. Any improvement in this parameter will be measured as change from baseline compared to measurement after 1 year of treatment. |
| Primary | Change in airway smooth muscle area | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. Any improvement in this parameter will be measured as change from baseline compared to measurement after 1 year of treatment. |
| Primary | Change in airway smooth muscle layer thickness | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. Any improvement in this parameter will be measured as change from baseline compared to measurement after 1 year of treatment. |
| Primary | Change in submucosal eosinophil number | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. Any improvement in this parameter will be measured as change from baseline compared to measurement after 1 year of treatment. |
| Primary | Change in epithelial integrity | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. Any improvement in this parameter will be measured as change from baseline compared to measurement after 1 year of treatment. |
| Primary | Change in collagen thickness | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. Any improvement in this parameter will be measured as change from baseline compared to measurement after 1 year of treatment, measured by electron microscopy. |
| Secondary | Change of cytokine and protein levels | through study completion, 52 weeks | To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood and bronchial washing. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of benralizumab treatment. |
| Secondary | Change in exacerbation rate | through study completion, 52 weeks | Measurement of the change in exacerbation rate in each severe eosinophilic asthmatic patient under benralizumab treatment for 52 weeks of treatment. |
| Secondary | Change in blood eosinophil levels | through study completion, 52 weeks | Measurement of the change in blood eosinophil levels in each severe eosinophilic asthmatic patient under benralizumab treatment for 52 weeks of treatment. |
| Secondary | dentification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1) | through study completion, 52 weeks | The identification of clinical characteristics of non-responders and super-responders. FEV1 change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment. FEV1 is the maximal amount of air you can forcefully exhale in one second measured by spirometry. |
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.
Papers6
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/NCT06288516
GET https://conductscience.org/api/trials/v1/NCT06288516/registered