Blood levels and effects of 2 medicines for COPD; ver 1

• Research type

  Research Study

• Full title

  A randomised, double-blind, double-dummy, single dose, four way cross-over study to compare the pharmacokinetics and pharmacodynamics of GSK961081 and fluticasone propionate when administered alone, concurrently and as a combination blend in healthy subjects (HMR code 11-008)

• IRAS ID

  80479

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2011-001828-38

• ISRCTN Number

  N/A

• Research summary

  People with chronic obstructive pulmonary disease (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'll test 2 inhaled medicines for COPD ?? one is an experimental new medicine (GSK961081), and the secondfluicasone propionate) is already widely used in many countries.GSK961081 anfluicasone propionate will be used together to treat COPD. This will be the first time that They'll be taken from the same inhaler. We??re doing this study in healthy volunteers to find out if blood levels and effects of the 2 medicines taken separately are the same as when they??re taken together ?? either from separate inhalers or from a single inhaler.24 healthy men and women, aged 18??50 years, will each take single doses of each of the following 4 treatments:?½ 800 æg GSK961081?½ 500 æfluicasone propionate?½ 800 æg GSK961081 and 500 æfluicasone propionate (taken from separate inhalers)?½ 800 æg GSK961081 and 500 æfluicasone propionate (taken from the same, single inhaler)Participants will take up to 8 weeks to finish the study. They'll have 4 study sessions (They'll stay on the ward for 8 nights in total) and have 2 outpatient visits. A pharmaceutical company (GlaxoSmithKline) is funding the study.The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/0634

• Date of REC Opinion

  3 Jun 2011

• REC opinion

  Favourable Opinion