Severe Eosinophilic AsthmaEMPOWAIRNCT05440656
A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 13 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Eosinophilic Asthma
- What is being tested?
- Cohort
- How many people
- 152 participants
- Where
- 13 sitesGreece
- Study dates
- 29 Jun 2022to 13 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Private practices and hospital clinics specializing in the management of asthma in geographically diverse locations throughout Greece
Who may be able to join
- 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
Show all 10Show fewer
- 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.
- -Patients must provide a written Informed Consent prior to inclusion to the study
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Greece13 sites
Research Site
Alexandroupoli, 68100
Research Site
Athens, 11521
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Athens, 15125
Research Site
Athens, 17562
Research Site
Corfu, 49100
Research Site
Heraklion, 71500
Research Site
Ioannina, 45500
Research Site
Rio, 26504
Research Site
Thessaloniki, 55535
Research Site
Thessaloniki, 56429
Research Site
Thessaloniki, 57010
About this study
Official title: 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
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
- Conditions
- Severe Eosinophilic Asthma
- Being tested
- Cohort
- Keywords
- Severe Asthma, Home Spirometry, Activity Tracker, Benralizumab
- Medical subject headings
- Pulmonary Eosinophilia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CohortDrug
Participants with Severe Eosinophilic Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks after the initiation of the treatment
Secondary outcomes (18)
Change in St. George's Respiratory Questionnaire (SGRQ)
Estimation of the proportion of patients achieving a moderately efficacious change in respiratory health status (≥ 8-point reduction from baseline in SGRQ total score)
Measured: 16 weeks after the initiation of the treatment
Change in St. George's Respiratory Questionnaire (SGRQ)
Estimation of the proportion of patients achieving a minimum clinically important improvement (≥ 4-point reduction in baseline SGRQ total score) and of those achieving a moderately efficacious change in respiratory health status (≥ 8-point reduction in baseline SGRQ total score)
Measured: after 4, 8, 32 and 48 weeks of treatment
Change in St. George's Respiratory Questionnaire (SGRQ)
Determination of predictors of early clinically important improvement in respiratory health status (measured by the SGRQ) at 4 weeks of treatment with benralizumab, and at 48 weeks post-benralizumab initiation among the 4-week SGRQ responders
Measured: after 4 and 48 weeks of treatment
Change in ACQ-6
Change in asthma control and the response rate as well as the response rate at 48 weeks post-benralizumab initiation among the 16-week ACQ-6 responders
Measured: after 4, 8, 16, 32, and 48 weeks of treatment
Change in the annual rate of clinically significant exacerbations
Change in the annual rate of clinically significant exacerbations (CSE) and identification of factors influencing the CSE rate
Measured: between the 48-week periods pre- and post-benralizumab initiation
change in asthma-related hospital-based health care resource utilization (HCRU)
Change in asthma-related hospital-based health care resource utilization (HCRU)
Measured: between the 48-week periods pre- and post-benralizumab initiation
Change from baseline in clinic-measured spirometric lung function indices
Change from baseline in clinic-measured spirometric lung function indices and description of the FEV1 improvement rate at 48 weeks post-benralizumab initiation among patients who will achieve clinically meaningful improvement in FEV1 at 16 weeks post-benralizumab initiation
Measured: after 16 and 48 weeks of benralizumab treatment
change from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use
Change from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use
Measured: after 4, 8, 16, 32 and 48 weeks of treatment
change in cumulative oral corticosteroid (OCS) burden
Change in cumulative oral corticosteroid (OCS) burden
Measured: etween the 16-week periods pre- and post-benralizumab initiation and the 48-week periods pre- and post-benralizumab initiation
change from baseline in anxiety and depression levels [assessed by the Hospital Anxiety and Depression Scale (HADS)]
Change from baseline in anxiety and depression levels [assessed by the Hospital Anxiety and Depression Scale (HADS)]
Measured: after 16 and 48 weeks of treatment
change from baseline in patient-reported sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)]
Change from baseline in patient-reported sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)]
Measured: after 16 and 48 weeks of treatment
change from baseline in work productivity and activity impairment [assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire]
Change from baseline in work productivity and activity impairment [assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire]
Measured: after 16 and 48 weeks of treatment
clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)
Clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)
Measured: over the 48-week treatment period
patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)
Patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)
Measured: after 48 weeks of treatment
Percentage of patients remaining on treatment with benralizumab
Treatment persistence rate on therapy
Measured: at 48 weeks of treatment
Percentage of patients having discontinued treatment with benralizumab
Percentage of patients having discontinued treatment with benralizumab
Measured: at 48 weeks of treatment
description of reasons for treatment discontinuation
description of reasons for treatment discontinuation
Measured: at 48 weeks of treatment
time to treatment discontinuation
time to treatment discontinuation
Measured: at 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start29 Jun 2022
- Primary completion13 Apr 2025
- Study completion13 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440656
- Sponsor's protocol ID
- D3250R00102
- Acronym
- EMPOWAIR
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05440656
- Acronym / sponsor ID
- EMPOWAIR / D3250R00102
- Conditions
- Severe Eosinophilic Asthma
- Keywords
- Severe Asthma, Home Spirometry, Activity Tracker, Benralizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 13 Apr 2025 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Private practices and hospital clinics specializing in the management of asthma in geographically diverse locations throughout Greece
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CohortParticipants with Severe Eosinophilic Asthma | Drug | – |
Primary outcome
Change in St. George's Respiratory Questionnaire (SGRQ)
Time frame: 16 weeks after the initiation of the treatment
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
18 secondary outcomes
Change in St. George's Respiratory Questionnaire (SGRQ)
Time frame: 16 weeks after the initiation of the treatment
Change in St. George's Respiratory Questionnaire (SGRQ)
Time frame: after 4, 8, 32 and 48 weeks of treatment
Change in St. George's Respiratory Questionnaire (SGRQ)
Time frame: after 4 and 48 weeks of treatment
Change in ACQ-6
Time frame: after 4, 8, 16, 32, and 48 weeks of treatment
Change in the annual rate of clinically significant exacerbations
Time frame: between the 48-week periods pre- and post-benralizumab initiation
change in asthma-related hospital-based health care resource utilization (HCRU)
Time frame: between the 48-week periods pre- and post-benralizumab initiation
Change from baseline in clinic-measured spirometric lung function indices
Time frame: after 16 and 48 weeks of benralizumab treatment
change from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use
Time frame: after 4, 8, 16, 32 and 48 weeks of treatment
change in cumulative oral corticosteroid (OCS) burden
Time frame: etween the 16-week periods pre- and post-benralizumab initiation and the 48-week periods pre- and post-benralizumab initiation
change from baseline in anxiety and depression levels [assessed by the Hospital Anxiety and Depression Scale (HADS)]
Time frame: after 16 and 48 weeks of treatment
change from baseline in patient-reported sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)]
Time frame: after 16 and 48 weeks of treatment
change from baseline in work productivity and activity impairment [assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire]
Time frame: after 16 and 48 weeks of treatment
clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)
Time frame: over the 48-week treatment period
patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)
Time frame: after 48 weeks of treatment
Percentage of patients remaining on treatment with benralizumab
Time frame: at 48 weeks of treatment
Percentage of patients having discontinued treatment with benralizumab
Time frame: at 48 weeks of treatment
description of reasons for treatment discontinuation
Time frame: at 48 weeks of treatment
time to treatment discontinuation
Time frame: at 48 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic Asthma, run by AstraZeneca at 13 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in St. George's Respiratory Questionnaire (SGRQ) (time frame: 16 weeks after the initiation of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.