Effects of FF & GW642444M on the electrical activity of the heart v1

• Research type

  Research Study

• Full title

  A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects (HMR code: 09-010)

• IRAS ID

  55841

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-015252-18

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  GW642444M and fluticasone 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 a day. We hope that a combination of GW642444M and FF will need to be taken only once a day. We??re doing this study to find out if repeated doses of GW642444M and FF have any important effects on the heart. We'll do that using electrocardiograms (ECGs), which painlessly record the electrical activity of the heart. To make sure that the study can detect any possible effects of GW642444M and FF on ECGs, We'll also give volunteers a single dose of moxifloxacin ?? an antibiotic that causes small and short-lived changes in ECGs. Moxifloxacin is a marketed medicine. In this study, there??ll be up to 85 healthy men and women, aged 18 to 65 years. Participants will take up to 13 weeks to finish the study ?? they??ll spend 13 days and nights on the ward, and have 2 outpatient visits. Each participant will have 4 study sessions. In each session they??ll take 7 daily doses of GW642444M and FF or placebo, and a single dose of moxifloxacin or placebo. GW642444M and FF is inhaled, and moxifloxacin is a tablet. When the participants are on the ward, We'll do many ECGs, take blood samples, and do standard safety tests. A pharmaceutical company (GlaxosmithKline) is funding the study. The study will take place at 1 centre in London. We'll recruit 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/IEC04/11

• Date of REC Opinion

  21 Jun 2010

• REC opinion

  Favourable Opinion