Cohort
DrugParticipants with Severe Eosinophilic Asthma
NCT Number: NCT05440656
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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Notify Me18 year–75 year
All sexes
Observational
Research Site, Alexandroupoli, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Participants with Severe Eosinophilic Asthma
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
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)
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)
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
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
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
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: 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
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
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
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)]
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: over the 48-week treatment period
Clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)
Time frame: after 48 weeks of treatment
Patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)
Time frame: at 48 weeks of treatment
Treatment persistence rate on therapy
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
AstraZeneca
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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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