Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.
POWER
Patient Outcomes Real World Evidence Registry (POWER): Patient Reported Outcomes in a Cohort of Canadian Adults With Severe Eosinophilic Asthma on Benralizumab.
1 other identifier
observational
170
1 country
20
Brief Summary
This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedStudy Start
First participant enrolled
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2024
CompletedJuly 1, 2024
June 1, 2024
5.5 years
October 11, 2018
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change of at least 0.5 units in ACQ-6 after initiation of benralizumab
ACQ-6 is able to identify the adequacy of asthma control in individual patients. Data will be presented as the proportion of patients achieving a change of at least 0.5 units following initiation of therapy.
Up to week 56 (from 1st dose of benralizumab)
Secondary Outcomes (9)
Number of exacerbations
Up to week 56 (from first dose of benralizumab)
Change in concomitant medications
Up to week 56 (from first dose of benralizumab)
Number of participants with Serious Adverse Events and hospitalizations
Up to week 56 (from first dose of benralizumab)
Asthma Quality of Life Questionnaire, Symptoms (AQLQ(S)+12)
Up to week 56 (from first dose of benralizumab)
Health care resource utilization
Up to week 56 (from first dose of benralizumab)
- +4 more secondary outcomes
Interventions
Patient Reported Outcomes (PROs) of health, quality of life, and economic outcomes during routine clinical practice.
Eligibility Criteria
Canadian adults (18+) with uncontrolled severe eosinophilic asthma.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Research Site
Calgary, Alberta, T2N 1N4, Canada
Research Site
Calgary, Alberta, T3B 0M3, Canada
Research Site
Edmonton, Alberta, T5H 4B9, Canada
Research Site
Edmonton, Alberta, T5J 3S9, Canada
Research Site
Red Deer, Alberta, T4N 1L1, Canada
Research Site
Sherwood Park, Alberta, T8H 0N2, Canada
Research Site
Vancouver, British Columbia, V5Z 4E1, Canada
Research Site
Vancouver, British Columbia, V6Z 1Y6, Canada
Research Site
Bathurst, New Brunswick, E2A 1A9, Canada
Research Site
Ajax, Ontario, L1S 2J5, Canada
Research Site
Burlington, Ontario, L7N 3V2, Canada
Research Site
Kitchener, Ontario, N2M 5E2, Canada
Research Site
North Bay, Ontario, P1B 4Y3, Canada
Research Site
Toronto, Ontario, M4V 1R2, Canada
Research Site
Toronto, Ontario, M5G 1E2, Canada
Research Site
Barrie, Ontaro, L4N 7L3, Canada
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
Research Site
Trois-Rivières, Quebec, G8T 7A1, Canada
Research Site
Regina, Saskatchewan, S4P 1Y8, Canada
Research Site
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erika Penz, MD
University of Saskatchewan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2018
First Posted
February 6, 2019
Study Start
November 12, 2018
Primary Completion
May 28, 2024
Study Completion
May 28, 2024
Last Updated
July 1, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share