Clinical trial NCT03833141: Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.
Official title: Patient Outcomes Real World Evidence Registry (POWER): Patient Reported Outcomes in a Cohort of Canadian Adults With Severe Eosinophilic Asthma on Benralizumab.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Eosinophilic Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian adults (18+) with uncontrolled severe eosinophilic asthma.

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 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

Eligibility 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.

Primary outcomes:
measure: Change of at least 0.5 units in ACQ-6 after initiation of benralizumab
timeFrame: Up to week 56 (from 1st dose of benralizumab)
Secondary outcomes:
measure: Number of exacerbations
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Change in concomitant medications
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Number of participants with Serious Adverse Events and hospitalizations
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Asthma Quality of Life Questionnaire, Symptoms (AQLQ(S)+12)
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Health care resource utilization
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: EuroQol 5 Dimension, 5 Level (EQ-5D-5L)
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Up to week 56 (from first dose of benralizumab)
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Up to week 56 (from first dose of benralizumab)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Red Deer
country: Canada
facility: Research Site
state: Alberta
city: Sherwood Park
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Bathurst
country: Canada
facility: Research Site
state: New Brunswick
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: North Bay
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Barrie
country: Canada
facility: Research Site
state: Ontaro
city: St-Charles-Borromee
country: Canada
facility: Research Site
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Regina
country: Canada
facility: Research Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Erika Penz, MD
role: PRINCIPAL_INVESTIGATOR
References: