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

Severe Eosinophilic Asthma Clinical Trial

— POWER  

Official title:

Patient Outcomes Real World Evidence Registry (POWER): Patient Reported Outcomes in a Cohort of Canadian Adults With Severe Eosinophilic Asthma on Benralizumab.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03833141
• Other study ID #: D3250R00041
• Status: Active, not recruiting
• Start date: November 12, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Pulmonary Eosinophilia
• Severe Eosinophilic Asthma

Intervention

Other:
• Survey Administration
Patient Reported Outcomes (PROs) of health, quality of life, and economic outcomes during routine clinical practice.

Locations

Country	Name	City	State
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Bathurst	New Brunswick
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	North Bay	Ontario
Canada	Research Site	Regina	Manitoba
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois Rivieres	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of exacerbations	The start of an exacerbation is defined as the start-date of systemic corticosteroids or start-date of a temporary increase in a stable oral corticosteroid background dose, or start-date of a hospital admission, whichever occurs earlier.; Data will be presented as an annualized exacerbation rate.	Up to week 56 (from first dose of benralizumab)
Secondary	Change in concomitant medications	Change in concomitant medications (i.e. oral corticosteroid usage) will be measured.	Up to week 56 (from first dose of benralizumab)
Secondary	Number of participants with Serious Adverse Events and hospitalizations	Assessment of safety and tolerability through measuring the overall change in number of serious adverse events and hospitalizations.; Data will be presented as the proportion of patients experiencing serious adverse events and hospitalizations.	Up to week 56 (from first dose of benralizumab)
Secondary	Asthma Quality of Life Questionnaire, Symptoms (AQLQ(S)+12)	The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma patients.; The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli).; Patients are asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions, and is presented as a score from 1 to 7, with lower overall scores indicating increasing impairement.; The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains.; Individual AQLQ(s)+12 Total or domain score changes of =0.5 are considered clinically meaningful.; Data will be presented as a mean score and change from baseline with a measure of dispersion.	Up to week 56 (from first dose of benralizumab)
Secondary	Health care resource utilization	Health Care Resource Utilization (HCRU) will be measured through the overall change in the number of hospitalization visits, visits to the emergency department, and presenteeism/absenteeism from school/work.	Up to week 56 (from first dose of benralizumab)
Secondary	EuroQol 5 Dimension, 5 Level (EQ-5D-5L)	The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).; The measurement of the EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. The index values, presented in country specific value sets, are a major feature of the EQ-5D instrument, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions.; Index values are presented on a continuum between 0 and 1, with values approaching 1 indicating increasing quality of life (utility).; Data will be presented as mean score as well as a change from baseline score with a measure of dispersion.	Up to week 56 (from first dose of benralizumab)
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM-9)	The TSQM-9 treatment satisfaction questionnaire is a measure of Effectiveness, Side effects, Convenience, and Global Satisfaction. The scores range from 0 to 100 with higher scores indicating greater satisfaction.; Data will be presented as a mean score with a change from baseline calculation including a measure of dispersion.	Up to week 56 (from first dose of benralizumab)
Secondary	Patient Global Impression of Change (PGIC)	The self-reported measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.; PGIC is a 7 point scale depicting a patient's rating of overall improvement.; Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."; Data will be presented as a mean score with a change from baseline calculation including a measure of dispersion.	Up to week 56 (from first dose of benralizumab)
Secondary	Patient Global Impression of Severity (PGI-S)	PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S item asks the participant to best describe how their asthma symptoms are now ("Check the one number that best describes how your asthma symptoms are now") on a 4-point scale scored as: "normal" (1), "mild" (2), "moderate" (3), or "severe" (4) .; Data will be presented as a mean score with a change from baseline calculation including a measure of dispersion.	Up to week 56 (from first dose of benralizumab)