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NCT04200326 | COMPLETED | Severe Uncontrolled Asthma

Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
Sponsor:

AstraZeneca

Brief 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.

Condition or disease

Severe Uncontrolled Asthma

Detailed Description:

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 5 participants
Official Title : Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma
Actual Study Start Date : 2019-12-20
Estimated Primary Completion Date : 2020-04-09
Estimated Study Completion Date : 2020-04-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma

Location Details

NCT04200326

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