Effect of fluticasone furoate and GW642444M in mild asthmatics; v1

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, three-way crossover, repeat dose pilot study comparing the effect of inhaled fluticasone furoate/GW642444M combination and fluticasone furoate on the allergen-induced early asthmatic response in subjects with mild asthma.

• IRAS ID

  38751

• Contact name

  Malcolm Boyce

• Sponsor organisation

  GlaxoSmithKline Research and Development

• Eudract number

  2009-016581-80

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Asthma affects about 1 in 12 adults and 1 in 8 children in the UK. Asthmatics get attacks of wheezing and breathlessness, caused by narrowing of the small tubes (bronchioles) that carry air in and out of the lungs. Attacks are mainly caused by allergens, infection, exercise or emotion.We hope that the study medicines will relax the bronchioles and block the production of substances thought to cause narrowing of the bronchioles.In this study, We'll test the safety and effects of the study medicines. To test their effects, participants will inhale a fine mist of allergen, and We'll measure their reaction.About 42 patients with mild asthma, aged 18-65, will take part in 3 study sessions. In each session, They'll take the study medicine daily, for 28 days. We'll test 2 different treatment combinations, so participants will take study medicine in 2 sessions, and dummy medicine in the other session. In each session, participants will make 2 visits to the unit. They'll need to stay on the research unit for 1 night in each session. Participants will take about 31 weeks to finish the study.A pharmaceutical company, GlaxoSmithKline, is funding the study.In the UK, this study will take place in 2 research units, 1 in London and 1 in Manchester. The units will recruit participants: by advertising (newspaper, radio, and websites); by word-of-mouth; from their volunteer databases; and via their websites.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/80

• Date of REC Opinion

  21 Dec 2009

• REC opinion

  Favourable Opinion