real-life first dose effect of fasenra in patients with severe uncontrolled asthma

Conditions: Severe Uncontrolled Asthma

Summary: this pilot study will use novel technologies to collect information about the patient experience before and early after starting fasenra (benralizumab) as standard of care for severe uncontrolled asthma in a real-world setting, to determine how the experience changes over time. any detection of an early, subjective first-dose effect in this pilot study will be further validated in a larger follow-up study.

primary objective: explore the use of novel technologies to detect early changes in quality of life (qol) within the first 4 weeks after first dose of fasenra for the treatment of severe uncontrolled asthma. endpoints: improvement in qol measures, and physical and mental well-being as assessed by an increase in positive facial expressions, positive keywords, and quality of life biomarkers, with a decrease in asthma symptoms and improvement in fev1 and pef within the first 4 weeks after beginning fasenra. target population: individuals aged 18-75 years with severe asthma uncontrolled (acq \>=1.5) on current medications (hd-ics/laba with/without other maintenance therapies except biologics). patients beginning fasenra asstandard of care as specified by nice guidelines. study duration: the study duration per patient will be approximately 6 weeks from the enrolment visit to end of recorded data. subjects will record data for 2 weeks prior to their first injection with fasenra and then for 4 more weeks post-injection. procedurespatients will be required to visit the study site 3 times (enrolment and onboarding visit, fasenra injection visit, last visit), and perform daily tasks at home in between site visits

Eligibility criteria:
inclusion criteria: * individuals aged 18-75 years with severe asthma uncontrolled (acq \>=1.5) on current medications (hd-ics/laba with/without other maintenance therapies except biologics). * patients beginning fasenra as standard of care as specified by nice guidelines. that is, patients having either 4 exacerbations in the previous year and an eosinophil count over 300 cells/ microliter or 3 exacerbations in the previous year and an eosinophil count over 400 cells/ microliter. * provision of informed consent prior to any study specific procedures * patients must have a smartphone that is compatible with the device software (ios and android). * availability of, and willingness to use, without reimbursement of any potential additional costs incurred, their computer and/or ios/android device for the collection and transmission of information * english speaking and reading (ability to understand icf, patient materials, the study app and to interact with the onboarding agent). exclusion criteria: * patients taking daily prednisolone (or equivalent) * patients currently taking a biologic medication or participating in a clinical study involving a biologic medication for a respiratory illness. * comorbid conditions that cause symptoms similar to those experienced with asthma (e.g./ cough, wheeze, breathlessness, or nighttime awakening). * patients with comorbidities that also significantly affect patient's quality of life and daily functioning as determined by the treating physician. * presence of other chronic pulmonary conditions (e.g./ copd) * patients that in the opinion of the physician are unlikely to complete 6 weeks of the study (example reasons: digital literacy, unwillingness/inability to interact with apps; historically poor adherence to study procedures)