GPRI, a Dutch research institute led by Prof. Janwillem Kocks, is setting up a new multi-country qualitative study, and we are looking for a medical professional in the United States to help us navigate country-specific activities, such as ethical approval and recruitment of pharmacies. Furthermore, to aid in the interpretation of the results, and join the publication and conference abstracts that follow from these results.
Study: Impact of Asthma
Design: Multi-country, Qualitative
Coordinator: Prof. Janwillem Kocks, GPRI, the Netherlands
Aim: To evaluate the impact of Acute Worsening Events on daily lives of patients with asthma
Recruitment through: Pharmacies
Target: 40 participants in the United States
Study duration: For participant, 13 – 17 weeks
First subject in: For the USA, aiming at February 2024.
Looking for: Medical professional to assist in country-specific ethical approval and recruitment of pharmacies.
Compensation: We project an investment of 19 hours, which is compensated at $200/hour.
Contact if interested: Yoran Gerritsma at asthmaimpact@gpri.nl
Study background: CompEx, a composite outcome for the evaluation of new asthma therapies, is defined as the first occurrence of an Acute Worsening Event or a severe exacerbation. CompEx events are ~3 times more likely than severe exacerbations (Fuhlbrigge et al., 2017) and, when used as primary outcome for trials, could allow for shorter trials that require fewer patients. An Acute Worsening Event is based on diary events (filled in twice daily, takes <10 minutes), capturing Peak Expiratory Flow (PEF), amount of reliever use, and a 1-item questionnaire on symptoms. In this study, we evaluate the impact of an Acute Worsening Event on the daily lives of patients with asthma through semi-structured interviews.
Reference:
Fuhlbrigge A. et al., (2017). A novel endpoint for exacerbations in asthma to accelerate clinical development: a post-hoc analysis of randomised controlled trials. The Lancet Respiratory Medicine, 5(7), 577–590.