Blood levels of inhaled GSK961081 and fluticasone furoate, version A
Research type
Research Study
Full title
An open label, six-period cross-over, single and repeat dose study to determine the pharmacokinetics of fluticasone furoate and GSK961081 when administered alone, in combination, or concurrently via the Ellipta. HMR code: 15-010
IRAS ID
187468
Contact name
Adeep Puri
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-003432-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 16 days
Research summary
The study medicine (Batefenterol [BAT]) is an experimental treatment for chronic obstructive pulmonary disease (COPD). People with COPD suffer from breathlessness, because the small tubes (bronchioles) that carry air in and out of the lungs have narrowed, usually because of heavy smoking. Often the lining of the bronchioles become inflamed and swollen.
In this study, we will test two inhaled treatments for COPD – one is the study medicine, and the second is fluticasone furoate (FF), which is an inhaled corticosteroid already prescribed by doctors in the UK as a combined treatment (FF/vilanterol) for COPD and asthma. Both BAT and FF make breathing easier. BAT works by relaxing the airways and FF reduces inflammation and swelling in the bronchioles.
We aim to find out the blood levels of FF when taken alone or with BAT, and blood levels of BAT when it’s taken alone or with FF at higher and lower doses. We also aim to find out safety and tolerability of single and repeated doses of FF and BAT, when taken together and alone. FF/vilanterol (100/25 mcg) is also included in the study treatments to allow comparisons to be made with that approved product. We will test single doses of 900 µg BAT and 300 µg FF, and repeated doses of 300 µg BAT and 100 µg FF for 7 days, alone or in combination – either from separate inhalers or from a single inhaler.
48 healthy volunteers, aged 18–64, will have 6 study sessions. Participants will take up to 15 weeks to finish the study. They’ll make 11 outpatient visits, and stay on the ward 9 times for 2–3 nights (21 nights in total).
A pharmaceutical company (GlaxoSmithKline) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
15/NI/0240
Date of REC Opinion
26 Nov 2015
REC opinion
Favourable Opinion