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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01928771
Registration number
NCT01928771
Ethics application status
Date submitted
16/08/2013
Date registered
27/08/2013
Date last updated
3/05/2017
Titles & IDs
Public title
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
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Scientific title
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting ß2 Agonist in Patients With Uncontrolled Asthma
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Secondary ID [1]
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0
D3250C00017
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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0
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Benralizumab
Treatment: Other - Placebo
Experimental: Benralizumab 30 mg q.4 weeks - Benralizumab administered subcutaneously every 4 weeks
Experimental: Benralizumab 30 mg q.8 weeks - Benralizumab administered subcutaneously every 8 weeks
Placebo comparator: Placebo - Placebo administered subcutaneously
Treatment: Other: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
Treatment: Other: Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
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Assessment method [1]
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The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
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Timepoint [1]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [1]
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Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL
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Assessment method [1]
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The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF
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Timepoint [1]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [2]
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Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations
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Assessment method [2]
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The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)
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Timepoint [2]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [3]
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Number of Patients With >=1 Asthma Exacerbations
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Assessment method [3]
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0
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Timepoint [3]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [4]
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Time to First Asthma Exacerbation
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Assessment method [4]
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Timepoint [4]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [5]
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Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL
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Assessment method [5]
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Timepoint [5]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [6]
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Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL
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Assessment method [6]
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Timepoint [6]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [7]
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Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL
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Assessment method [7]
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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.
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Timepoint [7]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [8]
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Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL
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Assessment method [8]
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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.
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Timepoint [8]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [9]
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Change in Asthma Rescue Medication
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Assessment method [9]
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Change from baseline to week 48 in number of rescue medication use (puffs/day)
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Timepoint [9]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [10]
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Home Lung Function Assessment Based on Morning PEF
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Assessment method [10]
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Change from baseline to week 48 in home lung function morning peak expiratory flow \[PEF\]
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Timepoint [10]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [11]
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Home Lung Function Assessment Based on Evening PEF
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Assessment method [11]
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Change from baseline to week 48 in home lung function evening peak expiratory flow \[PEF\]
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Timepoint [11]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [12]
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Proportion of Night Awakening Due to Asthma
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Assessment method [12]
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Change from baseline to Week 48 on proportion of night awakening due to asthma
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Timepoint [12]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [13]
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Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL
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Assessment method [13]
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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.
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Timepoint [13]
0
0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [14]
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Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL
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Assessment method [14]
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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.
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Timepoint [14]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [15]
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Pharmacokinetics of Benralizumab
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Assessment method [15]
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Mean PK concentrations at each visit
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Timepoint [15]
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Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56
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Secondary outcome [16]
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Immunogenicity of Benralizumab
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Assessment method [16]
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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.
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Timepoint [16]
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Pre-treatment until end of follow-up
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Secondary outcome [17]
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Extend of Exposure
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Assessment method [17]
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Extend of exposure is defined as duration of treatment in days
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Timepoint [17]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [18]
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Mean Change From Baseline to Week 48 in AQLQ(S)+12
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Assessment method [18]
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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.
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Timepoint [18]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [19]
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Mean Change From Baseline to Week 48 in EQ-5D-5L VAS
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Assessment method [19]
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EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
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Timepoint [19]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [20]
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Mean Work Productivity Loss Due to Asthma
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Assessment method [20]
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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. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.
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Timepoint [20]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [21]
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Mean Productivity Loss Due to Asthma in Classroom
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Assessment method [21]
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WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes
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Timepoint [21]
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0
Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [22]
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Number of Participants That Utilized Health Care Resources
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Assessment method [22]
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Timepoint [22]
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Immediately following the first administration of study drug through Study Week 48.
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Secondary outcome [23]
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Patient and Clinician's Responder Assessment to Treatment
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Assessment method [23]
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CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.
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Timepoint [23]
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Immediately following the first administration of study drug through Study Week 48
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Eligibility
Key inclusion criteria
1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
2. Female and Male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.
* For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
* For subjects ages 12-17, the ICS dose must be =500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.
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Minimum age
12
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
* Affect the safety of the patient throughout the study
* Influence the findings of the studies or their interpretations
* Impede the patient's ability to complete the entire duration of study
3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/04/2016
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Sample size
Target
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Accrual to date
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Final
2681
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Bedford Park
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Recruitment hospital [2]
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Research Site - Box Hill
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Recruitment hospital [3]
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Research Site - Clayton
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Research Site - Concord
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Research Site - Frankston
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Research Site - Nedlands
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Research Site - New Lambton Heights
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Research Site - Parkville
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Research Site - Prahran
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Research Site - Randwick
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Recruitment hospital [11]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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- Bedford Park
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Recruitment postcode(s) [2]
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- Box Hill
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- Clayton
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- Concord
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Recruitment postcode(s) [5]
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- Frankston
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Recruitment postcode(s) [6]
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- Nedlands
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Recruitment postcode(s) [7]
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- New Lambton Heights
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Recruitment postcode(s) [8]
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- Parkville
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Recruitment postcode(s) [9]
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- Prahran
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Recruitment postcode(s) [10]
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- Randwick
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Recruitment postcode(s) [11]
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- Woolloongabba
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Mississippi
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Santo André
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Brazil
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Brazil
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Brazil
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Bulgaria
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Pernik
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Bulgaria
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Pleven
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Bulgaria
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Ruse
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Bulgaria
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Samokov
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Bulgaria
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Sliven
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Velingrad
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Bulgaria
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Yambol
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Hanoi
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.
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Trial website
https://clinicaltrials.gov/study/NCT01928771
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Trial related presentations / publications
Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14. Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22. Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14. Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15. Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23. Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct. DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4. Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1. Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.
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Public notes
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Contacts
Principal investigator
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Eugene R. Bleecker, MD, Professor of Medicine
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Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157
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No information has been provided regarding IPD availability
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01928771
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