Mechanistic study of fevipriprant in moderate to severe asthma
Research type
Research Study
Full title
Randomized, subject and investigator blinded, placebo-controlled study to demonstrate the anti-inflammatory effect of fevipiprant (QAW039) in moderate-severe asthma patients with high sputum and blood eosinophils
IRAS ID
264773
Contact name
Amin Salehi
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-004381-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 15 days
Research summary
This study will look at the anti-inflammatory effects of a drug called fevipiprant (also known as QAW039) in patients with moderate-severe asthma, with high levels of eosinophils.
Eosinophils are a type of cell involved in the immune system, which fights infection. At high levels, however, eosinophils can cause inflammation in the airways. They can be found in blood and sputum (phlegm) of patients with asthma; high levels of eosinophils are usually associated with more severe asthma.
Fevipiprant works by blocking a receptor called DP2, present on cells associated with inflammation such as eosinophils. By blocking this receptor, the number of eosinophils in the lungs of patients with asthma is reduced.
In this study, patients with asthma, who have high levels of eosinophils, will take one tablet each morning for 12 weeks. Tablets will either be fevipiprant or a placebo (dummy drug with no active ingredient). Half of the patients will receive the drug and half will receive placebo; this will be randomly decided by a computer and neither the patient nor their doctor will know what the patient receives, this is known as double-blind.
To examine the anti-inflammatory effects of fevipiprant, patients will provide samples of blood and sputum, which will be analysed in a lab, looking at cells that play an important role in inflammation, e.g. eosinophils, Th2/Tc2 cells, and ILC2 cells. This analysis will be done before, during and after treatment, to look at changes in results over time.
Samples of blood and sputum will also be collected from a small group of healthy volunteers (HVs), to compare with results from patients.
Between August 2019 and November 2020, a total of 58 participants (10 HVs and 48 patients with asthma) will be recruited globally, from 5 countries. 13 participants (2 HVs and 11 patients with asthma) will be recruited in the UK.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0410
Date of REC Opinion
23 Oct 2019
REC opinion
Further Information Favourable Opinion