Trial · NCT06465485
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient populationa and by subgroups of baseline background therapy | within 40 weeks after the first administration | Main outcomes: Proportion of patients with at least one controller medication category reduction at end of reduction phase * discontinuation of LTRA, or * discontinuation of LAMA, or * getting to MD ICS/LABA or * getting to LD ICS/LABA Supportive outcomes: * Proportion of patients with individual category reduction at end of reduction phase * Proportion of patients with ≥2 category reductions in controller medication * In sub-group of patients who meet reduction criteria * proportion of patients with at least one controller medication category reduction, * proportion of patients with individual category reduction * proportion of patients with ≥2 reductions in controller medication at end of reduction phase |
| Secondary | To assess standard asthma efficacy measures for benralizumab treated patients when reducing their standard of care asthma controller regimen in the overall patient population a and by subgroups of baseline background therapy | From 16~40 weeks | * Change in pre-BD FEV1 from beginning of reduction phase to end of reduction phase * Change in ACQ-5 and SGRQ from beginning of reduction phase to end of reduction phase * Proportion of patients with no deterioration (defined as ACQ-5 change \<0.5 since last visit and FEV1 \< -100mL compared to beginning of reduction phase) during reduction phase |
| Secondary | To assess if reductions in background therapies achieved at end of reduction phase aremaintained until end of maintenance phase in the overall patient population a and by subgroups of baseline background therapy | From 32-56 weeks | •Proportion of patients at the end of the maintenance phase who use the same background therapy that they achieved at the end of the reduction phase |
| Secondary | To assess standard asthma efficacy measures for benralizumab treated patients at induction phase in the overall patient population and by subgroups of baseline background therapy | from 0-16 weeks | * Change in FEV1 from beginning of induction phase to end of induction phase * Change in ACQ-5 and SGRQ from beginning of induction phase to end of induction phase * Proportion of patients achieving ACQ-5 MCID improvement (defined as change in ACQ-5 ≤-0.5 compared to beginning of induction phase) and SGRQ MCID improvement (defined as change in SGRQ ≤-4 compared to beginning of induction phase) during induction phase |
| Secondary | To assess overall asthma exacerbation rate during the study of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy | within 56 weeks after first administration | * Annualized asthma exacerbation rate during the study (from first dose to EOT) and 1-year baseline period * Change in annualized asthma exacerbation rate during study phase vs. 1-year baseline period Annualized asthma exacerbation rate Defined as Number of exacerbations×365.25/(Follow-Up Date-First Benralizumab dose date+1) |
| Secondary | To assess biomarkers of severe eosinophilic asthma patients treated with benralizumab in the overall patient population and by subgroups of baseline background therapy | from -1 week to 56 week | Baseline and follow-up visits, and change from baseline: * Blood EOS * FeNO * Total IgE |
| Secondary | To assess if reductions in background therapies achieved at end of reduction phase aremaintained until end of maintenance phase in the overall patient population a and by subgroups of baseline background therapy | From 40-56 weeks | •Change in ACQ-5, SGRQ and FEV1 from the end of the reduction phase to the end of the maintenance phase |
| Other | To assess the changes in small - airway lung function indicators among patients treated with benralizumab in the overall patient populationa and by subgroups of baseline background therapy over the course of the study | from -1 week to 56 week | Change in small - airway lung function indicators from baseline to the end of the maintenance phase: * FEF 50% * FEF 75% * MMEF＆MMEF%pred |
| Other | To explore relationship between baseline characteristic and asthma control level at baseline | -1 week | Baseline characteristics and asthma control levels at baseline |
| Other | To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control | from -1 week to 60 week | Frequency of Adverse Events/Serious Adverse Events |
| Other | To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control | from -1 week to 56 week | Vital Signsb |
| Other | To assess the safety and tolerability of benralizumab during the study in patients with severe eosinophilic asthma, while reducing their standard of care asthma controller regimen and maintaining asthma symptom control | -1 week, 16 week, 40 week, 56 week | Laboratory variables (chemistry and hematology) |
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.
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