Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab. (POWER)

AstraZeneca

Status: Completed

Conditions: Severe Eosinophilic Asthma

Treatments: Other: Survey Administration

Study type: Observational

Funder types: Industry

Identifiers

NCT03833141

D3250R00041

Details and patient eligibility

About

This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.

Full 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 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

Enrollment: 170 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

  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

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.