Trial · NCT04102800
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blood eosinophil counts during a clinical deterioration whilst on benralizumab | up to 56 or 80 weeks | |
| Primary | Fall in lung function, as measured by FEV1, during a clinical deterioration whilst on benralizumab. | up to 56 or 80 weeks | |
| Primary | Change in asthma symptom scores during a clinical deterioration whilst on benralizumab. | up to 56 or 80 weeks | |
| Primary | The number of patients progressing to rescue oral corticosteroids during a clinical deterioration whilst on benralizumab. | up to 56 or 80 weeks | |
| Secondary | Measurement of the magnitude of response to benralizumab - oral steroid reduction with benralizumab at 56 weeks | 56 weeks | proportion of patients who reduce high dose steroid courses and/or maintenance steroid dose by \>=25%, 50%, 75% and 100% |
| Secondary | Measurement of the magnitude of response to benralizumab - numbers of participants with and early and final good response | 16, 24 weeks, 1 year | Early (16/24 weeks): A GETE response of 'good' or 'excellent' to treatment with benralizumab as determined by the study physician. Final (one year): defined as a reduction of high dose corticosteroid courses by \>=50% compared to the previous year and/or reduction of maintenance oral steroid dose by \>=50% |
| Secondary | Measurement of the magnitude of response to benralizumab - inflammatory markers at 16 and 56 weeks compared to baseline | 16, 56 weeks | FBC to include Blood eosinophils, sputum eosinophils, blood neutrophil counts |
| Secondary | Measurement of the magnitude of response to benralizumab - inflammatory markers at 16 and 56 weeks compared to baseline | 16, 56 weeks | Measurement of exhaled nitric oxide |
| Secondary | Measurement of the magnitude of response to benralizumab - change in lung function, as measured by FEV1, at 16, 24 and 56 weeks compared to baseline | 16, 24 and 56 weeks | FEV1 post salbutamol on spirometry and FEV1 in daily diary |
| Secondary | Measurement of the magnitude of response to benralizumab - change in lung function at 16, 24 and 56 weeks compared to baseline | 16, 24 and 56 weeks | peak expiratory flow from the daily electronic meter |
| Secondary | Measurement of the magnitude of response to benralizumab - change in patient reported outcomes at 16,24 and 56 weeks compared to baseline | 16, 24 and 56 weeks | Completion of health outcome questionnaires |
| Secondary | Identifying predictors of treatment response | 16 weeks and 1 year | Patients will be classified into treatment responders and non-responders. Logistic regression will be used to identify the predictive value of improvement in early clinical response indicators at 16 weeks on 12 month treatment response. |
| Secondary | Comparing patient reported outcome measures | 16, 24 and 56 weeks | Correlation of completed questionnaires: Scores, and changes in scores, from the SAQ will be correlated with the SGRQ and mini-AQLQ. The SAQ score will be evaluated against demographic features at baseline. |
| Secondary | Onset of clinical response | up to 56 or 80 weeks | Time to first exacerbation and change in FEV1 with time. |
| Secondary | Exploratory Microbiomics | baseline, 4, 16 and 56 weeks, during exacerbation visits | Samples will be stored for later laboratory biomarker measurements. To assess possible biomarkers of response |
| Secondary | Exploratory viromics | baseline, 4, 16 and 56 weeks, during exacerbation visits | Samples will be stored for later laboratory biomarker measurements. To assess possible biomarkers of response |
| Secondary | Exploratory transcriptomics | baseline, 4, 16 and 56 weeks, during exacerbation visits | Samples will be stored for later laboratory biomarker measurements. To assess possible biomarkers of response |
| Secondary | Exploratory biomarkers related to asthmatic airway inflammation, corticosteroid signalling and putative inflammatory pathways | baseline, 4, 16 and 56 weeks, during exacerbation visits | Samples will be stored for later laboratory biomarker measurements. To assess possible biomarkers of response |
| Other | Validation of home spirometry with video supported tests | Baseline, 2 and 24 weeks | Comparison of spirometry done on site with another done off site with video support from the study team. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04102800/registered