Blood levels of increasing doses of FF & a fixed dose of VI; version 1

• Research type

  Research Study

• Full title

  An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. (HMR code: 10-009)

• IRAS ID

  61645

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-021717-22

• ISRCTN Number

  N/A

• Research summary

  Vilanterol (VI) anfluicasone furoate (FF) are experimental new medicines for treating asthma and chronic obstructive pulmonary disease (COPD). Similar medicines are currently available, but they must be taken twice daily. We hope that a combination of VI and FF will need to be taken only once daily. We're doing this study to find out what happens to blood levels of the 2 medicines if the dose of FF is increased, but the dose of VI stays the same. We'll give 24 healthy men and women, aged 18-65 years, 3 different single doses of the study medicines, in 3 study sessions. After each dose, take 17 blood samples over 48 h. also check pulse rate, blood pressure and ECG. If participants consent, We'll also study how genes (pieces of DNA) affect the way the body responds to or handles the medicines. Participants will take up to 7 weeks to finish the study. They'll make up to 6 outpatient visits, and They'll stay on the ward for 6 nights (2 nights in a row in each session). 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

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/23

• Date of REC Opinion

  28 Sep 2010

• REC opinion

  Further Information Favourable Opinion