11-020 Effects of inhaled GSK573719 & Vilanterol on the ECG; version 1

• Research type

  Research Study

• Full title

  A randomised, placebo-controlled, incomplete block, four period crossover , repeat dose study to evaluate the effect of the inhaled GSK573719/Vilanterol combination and GSK573719 monotherapy on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects. (11-020)

• IRAS ID

  93404

• Contact name

  Benjamin van Hecke

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2011-004543-44

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  GSK573719 and vilanterol are experimental new medicines for treating chronic obstructive pulmonary (lung) disease (COPD - it's what used to be known as 'chronic bronchitis and emphysema'). Similar medicines are already available, but they must be taken twice daily. We hope that a combination of GSK573719 and vilanterol will need to be taken only once daily. We??re doing this study to find out if repeated doses of GSK573719/vilanterol 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 GSK573719/vilanterol 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 at least 100 healthy men and women, aged 18 to 65 years. Participants will take up to 16 weeks to finish the study ?? they??ll spend 13 days and nights on the ward, and have 2 outpatient visits (screening and follow-up). Each participant will have 4 study sessions. In each session, they??ll inhale 10 daily doses of study medicine, and take 1 tablet. They??ll take 4 of the following 5 treatments: GSK573719; 2 different dose levels of GSK573719/vilanterol; a single dose of moxifloxacin; or placebo. We'll use placebo inhalers and placebo tablets, so participants don??t know which treatment they??re taking. 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

  11/IE/0177

• Date of REC Opinion

  8 Dec 2011

• REC opinion

  Further Information Favourable Opinion