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

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ClinicalTrials.gov Identifier: NCT03833141
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment
Severe Eosinophilic Asthma Other: Survey Administration

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

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Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Outcomes Real World Evidence Registry (POWER): Patient Reported Outcomes in a Cohort of Canadian Adults With Severe Eosinophilic Asthma on Benralizumab.
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


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


Primary Outcome Measures :
  1. Change of at least 0.5 units in ACQ-6 after initiation of benralizumab [ Time Frame: Up to week 56 (from 1st dose of benralizumab) ]

    ACQ-6 is able to identify the adequacy of asthma control in individual patients.

    Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma.



Secondary Outcome Measures :
  1. Number of exacerbations [ Time Frame: Up to week 56 (from first dose of benralizumab) ]
    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.

  2. Change in concomitant medications [ Time Frame: Up to week 56 (from first dose of benralizumab) ]
    Change in concomitant medications (i.e. oral corticosteroid usage) will be measured.

  3. Number of participants with Serious Adverse Events and hospitalizations [ Time Frame: Up to week 56 (from first dose of benralizumab) ]
    Assessment of safety and tolerability through measuring the overall change in number of serious adverse events and hospitalizations.

  4. Asthma Quality of Life Questionnaire, Symptoms (AQLQ(S)+12) [ Time Frame: Up to week 56 (from first dose of benralizumab) ]

    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.


  5. Health care resource utilization [ Time Frame: Up to week 56 (from first dose of benralizumab) ]
    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.

  6. EuroQol 5 Dimension, 5 Level (EQ-5D-5L) [ Time Frame: Up to week 56 (from first dose of benralizumab) ]

    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).


  7. Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Up to week 56 (from first dose of benralizumab) ]
    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.

  8. Patient Global Impression of Change (PGIC) [ Time Frame: Up to week 56 (from first dose of benralizumab) ]

    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."


  9. Patient Global Impression of Severity (PGI-S) [ Time Frame: Up to week 56 (from first dose of benralizumab) ]
    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) .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Canadian adults (18+) with uncontrolled severe eosinophilic asthma.
Criteria

Inclusion Criteria:

  1. Are prescribed benralizumab during routine clinical practice;
  2. 18 years of age or older;
  3. 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 OCS;
  4. ACQ-6 score ≥ 1.5;
  5. Can understand the requirements of the study and provide informed consent to participate in this study;
  6. Agree to abide by the study protocol and its restrictions and can complete all aspects of the study, including all visits.

Exclusion Criteria:

  1. 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;
  2. Patients currently participating (i.e. have not completed) in any other clinical trial including those with biologic treatment;
  3. Patients with other documented lung disease other than asthma and not within reimbursed label.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833141


Contacts
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Contact: Stephen Noorduyn 1-800-565-5877 ext 47432 stephen.noorduyn@astrazeneca.com
Contact: Alain Gendron alain.gendron@astrazeneca.com

Locations
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Canada, Alberta
Investigational Site Recruiting
Edmonton, Alberta, Canada, T5H 4B9
Investigational Site Recruiting
Edmonton, Alberta, Canada, T5J 3S9
Investigational Site #3 Recruiting
Edmonton, Alberta, Canada, T8H 0N2
Canada, Ontario
Investigational Site #4 Recruiting
Kitchener, Ontario, Canada, N2M 5E2
Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 1E2
Canada, Quebec
Investigational Site #5 Not yet recruiting
Montreal, Quebec, Canada, H4A 2E3
Canada, Saskatchewan
Investigational Site Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Erika Penz, MD University of Saskatchewan

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03833141     History of Changes
Other Study ID Numbers: D3250R00041
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Benralizumab
Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Anti-Asthmatic Agents
Respiratory System Agents