This study aims to assess health and quality of life outcomes in patients treated with benralizumab, within a Belgian Real-World setting. To prove the clinical value of benralizumab in a Real-World setting, the study will document the effect of benralizumab within a time frame of 112 weeks after initiation of treatment.
The aim and objective of this single arm, prospective observational study is to provide supporting RWE on the symptom relief of asthma patients qualified for benralizumab therapy in Belgium. The PRO measures consist of the Asthma Control Questionnaire (ACQ 6) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S), healthcare resource utilization (HCRU) and treatment satisfaction (TSQM-9). In addition change in daily OCS use and rate of exacerbations after initiation of benralizumab in real-world setting will be assessed
Study Type
OBSERVATIONAL
Enrollment
76
Research Site
Brussels, Belgium
Research Site
Charleroi, Belgium
Research Site
Edegem, Belgium
Research Site
Erpent, Belgium
change in patient-reported asthma related symptoms
assessed with the Asthma Control Questionnaire (ACQ-6). The primary outcome variable (asthma control responder) is defined as a patient who had an at least (≥) 0.5-unit improvement in ACQ-6 score.
Time frame: up to 6 months after initiation of benralizumab
Change in patient-reported asthma related symptoms up to 112 weeks after initiation of benralizumab in a real-world setting
assessed with the Asthma Control Questionnaire (ACQ-6). The primary outcome variable (asthma control responder) is defined as a patient who had an at least (≥) 0.5-unit improvement in ACQ-6 score.
Time frame: up to 112 weeks after initiation of benralizumab
change in daily OCS use following initiation of benralizumab in real-world setting
Percent change from baseline daily OCS dose
Time frame: up to 112 weeks after initiation of benralizumab
change in asthma status in a real-world setting
assessed with the Global Impression of Severity (PGI-S). The PGI-S score will be categorized according to the following responses post-baseline: very mild, mild, moderate, severe or very severe. PGI-S at baseline, week 2, 4, 8, 24, 56, 80 and 112 will be presented descriptively
Time frame: up to 112 weeks after initiation of benralizumab
Rate of exacerbations after initiation of benralizumab in a real-world setting
assessed with the Number of exacerbations
Time frame: up to 112 weeks after initiation of benralizumab
change of disease severity in a real-world setting
Assessed with the Global Impression of Change (PGI-C). The PGI-C score will be categorized according to the following responses post-baseline: much better; moderately better; a little better; about the same; a little worse; moderately worse; and much worse. PGI-C responder endpoint (a little better, moderately better, much better) will be summarised by visit for patients.
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Research Site
Kortrijk, Belgium
Research Site
La Louvière, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Research Site
Mechelen, Belgium
Research Site
Roeselare, Belgium
Time frame: up to 8 weeks after initiation of benralizumab
Healthcare resource utilization in a real-world setting
assessed with the Health Care Resource Utilization Questionnaire (HCRU). The HCRU will assess number of asthma-related ED/hospital admissions, number of visits to primary care physician or specialist, number of home visits by health care professional, number of pharmacy visits and number of work/school days lost due to asthma.
Time frame: up to 112 weeks after initiation of benralizumab
change in treatment satisfaction in a real-world setting
assessed with the Treatment Satisfaction Questionnaire for Medication (TSQM-9). The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. The TSQM-9 scores will be presented descriptively by domain with a focus on efficacy and satisfaction.
Time frame: up to 112 weeks after initiation of benralizumab