TWINKLE
Research type
Research Study
Full title
TWINKLE: Real-life first dose effect of Fasenra in patients with Severe Uncontrolled Asthma
IRAS ID
268666
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
AstraZeneca plc
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
The study will explore a novel (new) technology to collect information about the participant 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.
The study’s Primary objective will be to 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.
The main endpoint of the study is 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 (indicators, or "flags"), with a decrease in asthma symptoms and improvement in Forced Expiratory Volume in 1 minute (how much air can be forceful exhaled) and Peak Expiratory Flow (how fast air can be exhaled) within the first 4 weeks after beginning Fasenra.
For this small pilot study, approximately 10 participants with severe asthma uncontrolled on current medications will be recruited from one site in London, England.
The study duration per participant will be approximately 6 weeks from the enrolment visit to end of recorded data. Participants will record data for 2 weeks prior to their first injection with Fasenra and then for 4 more weeks post-injection.
Participants 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:
There is no intention to use this data for diagnostic purposes.
All data collected will be for the purpose of evaluating an individual participant’s daily QoL and well-being. No medicinal products will be evaluated directly for efficacy or safety purposes.REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/1476
Date of REC Opinion
21 Oct 2019
REC opinion
Further Information Favourable Opinion