QAW039 vs. placebo in patients with uncontrolled severe asthma
Research type
Research Study
Full title
A 52-week, multicentre, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma
IRAS ID
188865
Contact name
Diane S. Bonagura
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-002553-35
Duration of Study in the UK
2 years, 8 months, 3 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. Uncontrolled asthma has a prevalence of greater than 6 million patients worldwide.Currently, there is a need for well tolerated, easily-administered, anti-inflammatory
therapies. QAW039 is an experimental medicine being tested for the treatment of people with asthma. The 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). The aim of treatment is to determine if QAW039 can reduce the number of asthma attacks, make asthma symptoms better and improve quality of life.If a participant gives consent to take part, they will be randomly assigned to one of three treatment groups on an equal basis:
(1) QAW039 150 mg once daily
(2) QAW039 450 mg once daily
(3) Placebo to QAW039 once daily100 UK participants will be recruited at approx 20 sites and remain in the study for about 14 months. 846 participants with severe asthma aged 12 years and older will be recruited globally in to the study. Participants will be separated in to two groups based on their eosinophil (a type of blood cell) count. Participants will attend 12 study visits.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0500
Date of REC Opinion
20 Feb 2016
REC opinion
Further Information Favourable Opinion