Systemic Corticosteroids Avoidance Study in Severe Asthma Patients.
Research type
Research Study
Full title
A 52-week, multicenter, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study of fevipiprant once daily plus standard-of-care (SoC) for reduction of systemic corticosteroids (oral and parenteral) use in patients with severe asthma
IRAS ID
252415
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-000212-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 0 days
Research summary
Asthma presents a major global health burden. Despite existing therapies, there is still significant unmet medical need in asthma, with an estimated 300 million people affected worldwide. Annual worldwide deaths have been estimated at 250,000 (Masoli et al, 2004).\n\nCurrently there is a need for well tolerated, easily administered, anti-inflammatory therapies. QAW039 is an experimental medicine being tested for the treatment of patients with asthma. \n\nThe purpose of this study is to see if QAW039 works better than placebo (dummy drug) when taken with usual asthma medicines (Standard of Care treatment GINA steps 4 & 5). The aim of the study is to determine if QAW039 can is more effective than placebo in reducing the use of systemic corticosteroids (SCS) as there is a correlation between SCS use and Adverse Events (AEs). Sustained use of SCS is associated with significant side effects, including growth retardation in children, as well as osteoporosis, diabetes, cardiovascular adverse events, muscular weakness, skin atrophy and cataract. This means there is an advantage for AE avoidance for those patients that do not use any SCS. Asthma therapies like QAW039 that can reduce the need for SCS are urgently needed, especially if given orally.\nIf a participant gives consent to take part in this study and fulfils inclusion / exclusion criteria, they will enter a double blind period and be randomly assigned to one of three treatment groups in a 1:1:1 ratio according to participants eosinophil cell (a type of blood cell) count.\n(1) QAW039 150 mg once daily\n(2) QAW039 450 mg once daily\n(3) Placebo to QAW039 once daily\n\n10 UK participants will be recruited at 3 sites and remain in the study for about 66 weeks , attending 9 visits and receiving 7 telephone calls. Approximately 669 participants over the age of 18 are expected to be randomised globally.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0443
Date of REC Opinion
10 Dec 2018
REC opinion
Further Information Favourable Opinion