Proof of mechanism QAW039 (fevipirant) in eosinophilic COPD patients
Research type
Research Study
Full title
A multi-center, proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia
IRAS ID
259565
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-004267-32
Duration of Study in the UK
1 years, 2 months, 26 days
Research summary
Fevipiprant is an oral medication that works by blocking a receptor called DP2. A receptor is like a ‘receiver’ of chemical messages in the body and when this particular receptor is blocked, blood cells (such as eosinophils) that cause inflammation are prevented from moving into the lungs. If blood cells such as eosinophils move to the lungs and cause inflammation, airways may become narrow, and symptoms like cough, wheezing and shortness of breath can occur. Therefore, it is hypothesised that blocking the movement of eosinophils into the lungs with fevipiprant could reduce COPD symptoms. This study sets out to prove this mechanism by testing if fevipiprant works better at blocking the movement of eosinophils into the lungs than placebo (a ‘dummy’ medicine with no active ingredient), when taken with usual COPD medications. This will be measured by analysing the change from baseline of % eosinophils in the sputum (mucus/phlegm) from the lungs of COPD patients when taking fevipiprant vs placebo.
The study will also look at any side effects caused by taking fevipiprant.
In the UK it is expected that 15 participants will take part from approximately 5 trial sites.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0112
Date of REC Opinion
10 Apr 2019
REC opinion
Favourable Opinion