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Completed

NCT Number: NCT05440656

A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alexandroupoli, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

-Patients must provide a written Informed Consent prior to inclusion to the study

Exclusion criteria

  • 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

Treatment and study plan

Cohort

Drug

Participants with Severe Eosinophilic Asthma

Primary outcomes

  1. 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

Secondary outcomes

  1. 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 moderately efficacious change in respiratory health status (≥ 8-point reduction from baseline in SGRQ total score)

  2. Change in St. George's Respiratory Questionnaire (SGRQ)

    Time frame: after 4, 8, 32 and 48 weeks of treatment

    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)

  3. Change in St. George's Respiratory Questionnaire (SGRQ)

    Time frame: after 4 and 48 weeks of treatment

    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

  4. Change in ACQ-6

    Time frame: after 4, 8, 16, 32, and 48 weeks of treatment

    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

  5. Change in the annual rate of clinically significant exacerbations

    Time frame: between the 48-week periods pre- and post-benralizumab initiation

    Change in the annual rate of clinically significant exacerbations (CSE) and identification of factors influencing the CSE rate

  6. change in asthma-related hospital-based health care resource utilization (HCRU)

    Time frame: between the 48-week periods pre- and post-benralizumab initiation

    Change in asthma-related hospital-based health care resource utilization (HCRU)

  7. Change from baseline in clinic-measured spirometric lung function indices

    Time frame: after 16 and 48 weeks of benralizumab treatment

    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

  8. 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 from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use

  9. 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 in cumulative oral corticosteroid (OCS) burden

  10. 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 anxiety and depression levels [assessed by the Hospital Anxiety and Depression Scale (HADS)]

  11. 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 patient-reported sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)]

  12. 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

    Change from baseline in work productivity and activity impairment [assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire]

  13. clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)

    Time frame: over the 48-week treatment period

    Clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)

  14. patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)

    Time frame: after 48 weeks of treatment

    Patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)

  15. Percentage of patients remaining on treatment with benralizumab

    Time frame: at 48 weeks of treatment

    Treatment persistence rate on therapy

  16. Percentage of patients having discontinued treatment with benralizumab

    Time frame: at 48 weeks of treatment

    Percentage of patients having discontinued treatment with benralizumab

  17. description of reasons for treatment discontinuation

    Time frame: at 48 weeks of treatment

    description of reasons for treatment discontinuation

  18. time to treatment discontinuation

    Time frame: at 48 weeks of treatment

    time to treatment discontinuation

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: EMPOWAIR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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