NCT03833141Completed
Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.
Patient Outcomes Real World Evidence Registry (POWER): Patient Reported Outcomes in a Cohort of Canadian Adults With Severe Eosinophilic Asthma on Benralizumab.
Source: ClinicalTrials.gov · Last updated 1 Jul 2024
Brief summary (registry, in English)
This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 170 (actual)
- First submitted
- 11 Oct 2018
- Start date
- 12 Nov 2018
- Primary completion date
- 28 May 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT03833141
What you commit to
- Study type: Observational
- Participants enrolled: 170
- From 12 Nov 2018 to the primary completion date, 28 May 2024
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received benralizumab prior to the start of the study
Other illness
- Any of the following conditions are cause for exclusion from the study:
- Patients with other documented lung disease other than asthma and not within reimbursed label.
Other
- 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 currently participating (i.e. have not completed) in any other clinical trial including those with biologic treatment;
Criteria the registry did not label
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.