Status:
COMPLETED
Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.
Lead Sponsor:
AstraZeneca
Conditions:
Severe Eosinophilic Asthma
Eligibility:
All Genders
18-130 years
Brief Summary
This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.
Detailed Description
Benralizumab was launched in 2018 following regulatory approval in Canada and is now widely available for Canadian patients with severe eosinophilic asthma. This study is an observational cohort stud...
Eligibility Criteria
Inclusion
- The following individuals may be eligible to participate:
- Are enrolled in the benralizumab PSP;
- Are 18 years of age or older;
- Can understand the requirements of the study and provide informed consent to participate in this study;
- Agree to abide by the study protocol and the exclusion criteria and can complete all aspects of the study, including all visits.
- Are benralizumab naïve and have not previously received benralizumab prior to the start of this study
- AND
- Suffer from uncontrolled severe eosinophilic asthma meeting at least one of the following:
- Has blood eosinophil count ≥ 300 cells/μL AND experienced two or more clinically-significant exacerbations in the past 12 months; OR
- Has blood eosinophil count ≥ 150 cells/μL AND are treated chronically with oral corticosteroids (OCS); OR
- Sputum eosinophil levels of 3% and higher OR
- Have been previously treated with a biologic for severe asthma and previously met the above eosinophil counts (detailed in #1,2, or 3 above) prior to initiation of the previous biologic.
- AND
- ACQ-6 score ≥ 1.5
- Exclusion criteria:
- Any of the following conditions are cause for exclusion from the study:
- Patients currently enrolled in an interventional clinical study in parallel will be excluded from the study, except for patients who are in parallel documented in a national asthma registry;
- Patients who have previously received benralizumab prior to the start of the study
- Patients currently participating (i.e. have not completed) in any other clinical trial including those with biologic treatment;
- Patients with other documented lung disease other than asthma and not within reimbursed label.
Exclusion
Key Trial Info
Start Date :
November 12 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03833141
Start Date
November 12 2018
End Date
May 28 2024
Last Update
July 1 2024
Active Locations (20)
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1
Research Site
Calgary, Alberta, Canada, T2N 1N4
2
Research Site
Calgary, Alberta, Canada, T3B 0M3
3
Research Site
Edmonton, Alberta, Canada, T5H 4B9
4
Research Site
Edmonton, Alberta, Canada, T5J 3S9