Clinical trial NCT05440656: A Real World Study to Capture Clinical and Patient Centered Outcomes in Adults With Severe Eosinophilic Asthma Treated With Benralizumab.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Eosinophilic Asthma
Keywords: Severe Asthma, Home Spirometry, Activity Tracker, Benralizumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Private practices and hospital clinics specializing in the management of asthma in geographically diverse locations throughout Greece

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 16 weeks after the initiation of the treatment
Secondary outcomes:
measure: Change in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 16 weeks after the initiation of the treatment
measure: Change in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: after 4, 8, 32 and 48 weeks of treatment
measure: Change in St. George's Respiratory Questionnaire (SGRQ)
timeFrame: after 4 and 48 weeks of treatment
measure: Change in ACQ-6
timeFrame: after 4, 8, 16, 32, and 48 weeks of treatment
measure: Change in the annual rate of clinically significant exacerbations
timeFrame: between the 48-week periods pre- and post-benralizumab initiation
measure: change in asthma-related hospital-based health care resource utilization (HCRU)
timeFrame: between the 48-week periods pre- and post-benralizumab initiation
measure: Change from baseline in clinic-measured spirometric lung function indices
timeFrame: after 16 and 48 weeks of benralizumab treatment
measure: change from baseline in rescue medication use and in the proportion of nights with awakenings due to asthma requiring rescue medication use
timeFrame: after 4, 8, 16, 32 and 48 weeks of treatment
measure: change in cumulative oral corticosteroid (OCS) burden
timeFrame: etween the 16-week periods pre- and post-benralizumab initiation and the 48-week periods pre- and post-benralizumab initiation
measure: change from baseline in anxiety and depression levels [assessed by the Hospital Anxiety and Depression Scale (HADS)]
timeFrame: after 16 and 48 weeks of treatment
measure: change from baseline in patient-reported sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)]
timeFrame: after 16 and 48 weeks of treatment
measure: change from baseline in work productivity and activity impairment [assessed by the Work Productivity and Activity Impairment:Respiratory Symptoms (WPAI:RS) questionnaire]
timeFrame: after 16 and 48 weeks of treatment
measure: clinician-assessed overall response to treatment using the Clinician Global Impression of Change (CGIC)
timeFrame: over the 48-week treatment period
measure: patient-perceived overall response to treatment using the Patient Global Impression of Change (PGIC)
timeFrame: after 48 weeks of treatment
measure: Percentage of patients remaining on treatment with benralizumab
timeFrame: at 48 weeks of treatment
measure: Percentage of patients having discontinued treatment with benralizumab
timeFrame: at 48 weeks of treatment
measure: description of reasons for treatment discontinuation
timeFrame: at 48 weeks of treatment
measure: time to treatment discontinuation
timeFrame: at 48 weeks of treatment
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Corfu
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Rio
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
Study officials:
References: