Trial · NCT05440656
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 | Change in St. George's Respiratory Questionnaire (SGRQ) | 16 weeks after the initiation of the treatment | Estimation of the proportion of patients achieving a minimum clinically important improvement in respiratory health status (≥ 4-point reduction from baseline in SGRQ total score) in SEA patients initiated on benralizumab |
| Secondary | Change in St. George's Respiratory Questionnaire (SGRQ) | 16 weeks after the initiation of the treatment | Estimation of the proportion of patients achieving a moderately efficacious change in respiratory health status (≥ 8-point reduction from baseline in SGRQ total score) |
| Secondary | Change in St. George's Respiratory Questionnaire (SGRQ) | after 4, 8, 32 and 48 weeks of treatment | Estimation of the proportion of patients achieving a minimum clinically important improvement (≥ 4-point reduction in baseline SGRQ total score) and of those achieving a moderately efficacious change in respiratory health status (≥ 8-point reduction in baseline SGRQ total score) |
| Secondary | Change in St. George's Respiratory Questionnaire (SGRQ) | after 4 and 48 weeks of treatment | Determination of predictors of early clinically important improvement in respiratory health status (measured by the SGRQ) at 4 weeks of treatment with benralizumab, and at 48 weeks post-benralizumab initiation among the 4-week SGRQ responders |
| Secondary | Change in ACQ-6 | after 4, 8, 16, 32, and 48 weeks of treatment | Change in asthma control and the response rate as well as the response rate at 48 weeks post-benralizumab initiation among the 16-week ACQ-6 responders |
| Secondary | Change in the annual rate of clinically significant exacerbations | between the 48-week periods pre- and post-benralizumab initiation | Change in the annual rate of clinically significant exacerbations (CSE) and identification of factors influencing the CSE rate |
| Secondary | change in asthma-related hospital-based health care resource utilization (HCRU) | between the 48-week periods pre- and post-benralizumab initiation | Change in asthma-related hospital-based health care resource utilization (HCRU) |
| Secondary | Change from baseline in clinic-measured spirometric lung function indices | after 16 and 48 weeks of benralizumab treatment | Change from baseline in clinic-measured spirometric lung function indices and description of the FEV1 improvement rate at 48 weeks post-benralizumab initiation among patients who will achieve clinically meaningful improvement in FEV1 at 16 weeks post-benralizumab initiation |
| Secondary | change from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use | after 4, 8, 16, 32 and 48 weeks of treatment | Change from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use |
| Secondary | change in cumulative oral corticosteroid (OCS) burden | etween the 16-week periods pre- and post-benralizumab initiation and the 48-week periods pre- and post-benralizumab initiation | Change in cumulative oral corticosteroid (OCS) burden |
| Secondary | change from baseline in anxiety and depression levels [assessed by the Hospital Anxiety and Depression Scale (HADS)] | after 16 and 48 weeks of treatment | Change from baseline in anxiety and depression levels \[assessed by the Hospital Anxiety and Depression Scale (HADS)\] |
| Secondary | change from baseline in patient-reported sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)] | after 16 and 48 weeks of treatment | Change from baseline in patient-reported sleep quality \[assessed by the Pittsburgh Sleep Quality Index (PSQI)\] |
| Secondary | change from baseline in work productivity and activity impairment [assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire] | after 16 and 48 weeks of treatment | Change from baseline in work productivity and activity impairment \[assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire\] |
| Secondary | clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC) | over the 48-week treatment period | Clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC) |
| Secondary | patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC) | after 48 weeks of treatment | Patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC) |
| Secondary | Percentage of patients remaining on treatment with benralizumab | at 48 weeks of treatment | Treatment persistence rate on therapy |
| Secondary | Percentage of patients having discontinued treatment with benralizumab | at 48 weeks of treatment | Percentage of patients having discontinued treatment with benralizumab |
| Secondary | description of reasons for treatment discontinuation | at 48 weeks of treatment | description of reasons for treatment discontinuation |
| Secondary | time to treatment discontinuation | at 48 weeks of treatment | time to treatment discontinuation |
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.
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