Trial · NCT01914757
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | 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 Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF. |
| Secondary | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | |
| Secondary | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | |
| Secondary | Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint 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 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint 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 Use | Immediately following the first administration of study drug through Study Week 56. | Change from Baseline to Week 56 in number of Rescue medication use (puffs/day) |
| Secondary | Home Lung Function Assessments Based on PEF | Immediately following the first administration of study drug through Study Week 56. | Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow \[PEF\]) |
| Secondary | Proportion of Nights With Awakening Due to Asthma | Immediately following the first administration of study drug through Study Week 56. | Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma |
| Secondary | Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. | 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 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. | 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 | Number of Patients With >=1 Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 56 | |
| Secondary | Time to First Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 56 | |
| Secondary | Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations | Immediately following the first administration of study drug through Study Week 56. | Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated) |
| Secondary | Pharmacokinetics of Benralizumab | Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60 | Mean PK Concentration 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 first and 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 | Extent of Exposure | Immediately following the first administration of study drug through Study Week 56 | Extent of exposure is defined as the duration of treatment in days |
| Secondary | Mean Change From Baseline to Week 56 in AQLQ(S)+12 | Immediately following the first administration of study drug through Study Week 56 | 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 | Change From Baseline to Week 56 in EQ-5D-5L VAS | Immediately following the first administration of study drug through Study Week 56 | EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. |
| Secondary | Mean Work Productivity Loss Due to Asthma | Immediately following the first administration of study drug through Study Week 56 | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed. |
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/NCT01914757/registered