Effect of GSK2190915 on early asthmatic reactions; version 1

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, 3-period cross-over study to evaluate the effect of two doses of GSK2190915 on the allergen-induced early asthmatic response in subjects with mild asthma

• IRAS ID

  8060

• Contact name

  Malcolm Boyce

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2008-005205-19

• 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 medicine will block the production of substances thought to cause narrowing of the bronchioles, and be a useful addition to asthma treatments. In this study, We'll test the safety, blood levels and effects of the study medicine. To test its effects, participants will inhale a fine mist of allergen, and We'll measure their reaction. About 18 patients with mild asthma will take part in 3 study sessions. In each session, they??ll take the study medicine daily, for 3 days. We'll test 2 different dose levels, so participants will take study medicine in 2 sessions, and dummy medicine in the other session. In each session, participants will make 3 visits to the unit. They might need to stay on the research unit for 1 night in each session. Participants will take up to 15 weeks to finish the study. A pharmaceutical company, GlaxoSmithKline, is funding the study. This study will take place in research units in London and 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 - Central Research Ethics Committee

• REC reference

  08/H0718/68

• Date of REC Opinion

  27 Nov 2008

• REC opinion

  Further Information Favourable Opinion