A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.
EMPOWAIR
A Real World Multicenter 48 Week Prospective Cohort Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab in Routine Care Settings in Greece
1 other identifier
observational
152
1 country
13
Brief Summary
Severe eosinophilic asthma (SEA) is associated with poor disease control and compromised health-related quality of life (HRQoL), leading to a substantial psychosocial and economic disease burden. Benralizumab (Fasenra®), an interleukin (IL)-5-alpha receptor monoclonal antibody, is approved as an add-on maintenance treatment for SEA. This study aims at collecting real-world data that extend beyond the clinical effectiveness of benralizumab to the participant-reported impact of treatment on their HRQoL, sleep quality, depression, anxiety, work productivity and activity impairment, but also on treatment effectiveness. Recent technological advances in portable spirometers and wearable activity trackers (WAT) to increase physical activity for participants with asthma, even for older participants, allow this study to collect data on lung function parameters and physical activity from such devices for the first time at a country level in Greece. Using a multi-aspect approach, this study will generate real-world evidence on a broad range of both well-established clinical and novel patient-centered outcomes which are critical to the assessment of the therapeutic benefit both from the physician's and the participant's perspective. All main study outcomes will be examined at various timepoints throughout the course of the 48-week observation period, starting as early as 4 weeks after treatment initiation, thus enabling the identification of 'early' treatment responders with a closer focus on patients' physical and psychological well-being and HRQoL in addition to asthma control and lung function metrics
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2025
CompletedApril 15, 2026
April 1, 2026
2.8 years
June 13, 2022
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in St. George's Respiratory Questionnaire (SGRQ)
Estimation of the proportion of patients achieving a minimum clinically important improvement in respiratory health status (≥ 4-point reduction from baseline in SGRQ total score) in SEA patients initiated on benralizumab
16 weeks after the initiation of the treatment
Secondary Outcomes (18)
Change in St. George's Respiratory Questionnaire (SGRQ)
16 weeks after the initiation of the treatment
Change in St. George's Respiratory Questionnaire (SGRQ)
after 4, 8, 32 and 48 weeks of treatment
Change in St. George's Respiratory Questionnaire (SGRQ)
after 4 and 48 weeks of treatment
Change in ACQ-6
after 4, 8, 16, 32, and 48 weeks of treatment
Change in the annual rate of clinically significant exacerbations
between the 48-week periods pre- and post-benralizumab initiation
- +13 more secondary outcomes
Interventions
Participants with Severe Eosinophilic Asthma
Eligibility Criteria
Private practices and hospital clinics specializing in the management of asthma in geographically diverse locations throughout Greece
You may qualify if:
- Male or female outpatients aged 18 to 75 years (inclusive) at the time of benralizumab prescription
- Patients with physician-diagnosed Severe Eosinophilic Asthma SEA inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus long-acting β-agonists (LABA)
- Patients who have been prescribed but not yet initiated treatment with benralizumab according to the Summary of Product Characteristics (SmPC), prior to signed Informed Consent, and for whom the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study
- For patients that are not Oral Corticosteroid (OCS)-dependent: Blood eosinophil count (BEC) ≥150 cells/μL in the 2 weeks before benralizumab initiation and a historical value of ≥300 cells/μL during the previous year
- For OCS-dependent patients: BEC ≥150 cells/μL in the 2 weeks before benralizumab initiation or a historical value of ≥300 cells/μL during the previous year
- History of ≥1 documented Clinically Significant Exacerbations (CSE) in the 48 weeks prior to benralizumab initiation, and of ≥2 CSEs in the previous 24 months
- Patients must be willing and able to read and complete the study specific questionnaires
- Patients must be willing and able to use the study-specific wearable/handheld devices.
- Note: This requirement applies only at the time of benralizumab (Fasenra®) prescription. If a patient stops using any or both of the aforementioned devices for any reason during his/her participation in the study, (s)he may continue participating in the study and this will not be considered as a reason for withdrawal.
You may not qualify if:
- Patients that meet any of the contraindications to the administration of the benralizumab outlined in the SmPC
- Concomitant treatment with any other biologic agent for any indication
- Previous exposure to anti-IL5/ILR5 treatment
- Exposure to omalizumab in the past 6 months prior to benralizumab initiation
- Clinically important pulmonary disease other than asthma or ever been diagnosed with any disease, other than asthma, that is associated with elevated BEC
- Acute upper or lower respiratory infections within 8 weeks prior to the date of informed consent
- Heavy smokers with a \>20 pack-year smoking history
- Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women
- Known evidence of lack of adherence to asthma controller medications
- Use of immunosuppressive medication (including but not limited to: OCS \[for reasons other than asthma\], methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids \[for reasons other than asthma\] or any experimental anti-inflammatory therapy) within 3 months prior to the date of informed consent
- Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before benralizumab initiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Site
Alexandroupoli, 68100, Greece
Research Site
Athens, 11521, Greece
Research Site
Athens, 11527, Greece
Research Site
Athens, 12462, Greece
Research Site
Athens, 15125, Greece
Research Site
Athens, 17562, Greece
Research Site
Corfu, 49100, Greece
Research Site
Heraklion, 71500, Greece
Research Site
Ioannina, 45500, Greece
Research Site
Rio, 26504, Greece
Research Site
Thessaloniki, 55535, Greece
Research Site
Thessaloniki, 56429, Greece
Research Site
Thessaloniki, 57010, Greece
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
July 1, 2022
Study Start
June 29, 2022
Primary Completion
April 13, 2025
Study Completion
April 13, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.