Triple vs dual therapy in inadequately controlled asthma
Research type
Research Study
Full title
A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma
IRAS ID
211989
Contact name
Jose Vicente-Garcia
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2016-001304-37
Duration of Study in the UK
1 years, 7 months, 3 days
Research summary
GlaxoSmithKline (GSK) will be conducting the study 205715 in patients with difficult to treat asthma.
Currently some patients with difficult to treat asthma are given two drugs called Fluticasone Furoate (FF) and Vilanterol (VI) in one inhaler taken once a day.
FF is an inhaled corticosteroid that helps reduce inflammation (swelling and irritation) in the lungs and both VI and UMEC are medicines called bronchodilators that help open up and relax the muscles in the airways in people with asthma.
This study will compare the current treatment (FF/VI) against the dual treatment plus the drug Umeclidinium (UMEC) (i.e. three drugs in one inhaler, FF/VI+UMEC). This is also taken once a day. GSK wants to find out what effects, good or bad, FF/UMEC/VI has on people with difficult to treat asthma and how these effects compare with FF/VI. The study will provide information on how the body handles the drug, the effects of the drug on the body, and how well the drug is working.
About 2250 patients with difficult to treat asthma in 15 countries will take part in this study. Approximately 110 UK patients will participate in the study. The study will last between 32 weeks and 60 weeks. Patients will be asked to attend an initial clinic visit lasting 1 hour and then up to 8 clinic visits lasting 4 to 5 hours and a final follow-up assessment lasting 10 minutes, 7 days after completing the study.
The following assessments will be performed:
Medical and smoking history, heart monitoring, vital signs, physical exam, blood and urine tests, asthma specific quality of life questionnaires and breathing tests. In addition patients will have to complete a daily electronic diary and breathing test at home.The safety of participants will be continually assessed by a Safety Review Team.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0494
Date of REC Opinion
15 Nov 2016
REC opinion
Further Information Favourable Opinion