Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.
NCT ID: NCT03833141
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
170 participants
OBSERVATIONAL
2018-11-12
2024-05-28
Brief Summary
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Detailed Description
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This study is an observational cohort study of patient reported outcomes (PROs) within real-world settings for participants who are prescribed benralizumab for treatment of uncontrolled severe eosinophilic asthma. Patients will be recruited in select clinics across Canada.
Survey data for each participant in the study will be obtained at the following time-points:
* Baseline (Week 0)
* Short-term follow up: 1-, 2-, 4-, and 8-weeks after baseline
* Long-term follow-up: 24- and 56-weeks after baseline
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Survey Administration
Patient Reported Outcomes (PROs) of health, quality of life, and economic outcomes during routine clinical practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are 18 years of age or older;
* Can understand the requirements of the study and provide informed consent to participate in this study;
Exclusion Criteria
AND
* Suffer from uncontrolled severe eosinophilic asthma meeting at least one of the following:
1. Has blood eosinophil count ≥ 300 cells/μL AND experienced two or more clinically-significant exacerbations in the past 12 months; OR
2. Has blood eosinophil count ≥ 150 cells/μL AND are treated chronically with oral corticosteroids (OCS); OR
3. Sputum eosinophil levels of 3% and higher OR
4. 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
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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Erika Penz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
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Research Site
Calgary, Alberta, Canada
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Red Deer, Alberta, Canada
Research Site
Sherwood Park, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Bathurst, New Brunswick, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
North Bay, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Barrie, Ontaro, Canada
Research Site
Saint-Charles-Borromée, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Regina, Saskatchewan, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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D3250R00041
Identifier Type: -
Identifier Source: org_study_id
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