Trial · NCT01928771
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF |
| Secondary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL | Immediately following the first administration of study drug through Study Week 48. | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF |
| Secondary | Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations | Immediately following the first administration of study drug through Study Week 48. | The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated) |
| Secondary | Number of Patients With >=1 Asthma Exacerbations | Immediately following the first administration of study drug through Study Week 48. | |
| Secondary | Time to First Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 48. | |
| Secondary | Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | |
| Secondary | Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 48. | |
| Secondary | Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. |
| Secondary | Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 48. | Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. |
| Secondary | Change in Asthma Rescue Medication | Immediately following the first administration of study drug through Study Week 48. | Change from baseline to week 48 in number of rescue medication use (puffs/day) |
| Secondary | Home Lung Function Assessment Based on Morning PEF | Immediately following the first administration of study drug through Study Week 48. | Change from baseline to week 48 in home lung function morning peak expiratory flow \[PEF\] |
| Secondary | Home Lung Function Assessment Based on Evening PEF | Immediately following the first administration of study drug through Study Week 48. | Change from baseline to week 48 in home lung function evening peak expiratory flow \[PEF\] |
| Secondary | Proportion of Night Awakening Due to Asthma | Immediately following the first administration of study drug through Study Week 48. | Change from baseline to Week 48 on proportion of night awakening due to asthma |
| Secondary | Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 48. | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \<=0.75 indicates well-controlled asthma, scores between 0.75 to \<=1.5 indicate partly controlled asthma, and \>1.5 indicates not well controlled asthma. |
| Secondary | Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 48. | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \<=0.75 indicates well-controlled asthma, scores between 0.75 to \<=1.5 indicate partly controlled asthma, and \>1.5 indicates not well controlled asthma. |
| Secondary | Pharmacokinetics of Benralizumab | Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56 | Mean PK concentrations at each visit |
| Secondary | Immunogenicity of Benralizumab | Pre-treatment until end of follow-up | Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at \>=2 post baseline assessments (with \>=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. |
| Secondary | Extend of Exposure | Immediately following the first administration of study drug through Study Week 48. | Extend of exposure is defined as duration of treatment in days |
| Secondary | Mean Change From Baseline to Week 48 in AQLQ(S)+12 | Immediately following the first administration of study drug through Study Week 48. | AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of \>=0.5 are considered clinically meaningful. |
| Secondary | Mean Change From Baseline to Week 48 in EQ-5D-5L VAS | Immediately following the first administration of study drug through Study Week 48. | EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. |
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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