Effect of GSK2190915 in patients with severe asthma; ver A

• Research type

  Research Study

• Full title

  The efficacy of orally administered GSK2190915 as an add-on to current therapy in subjects with moderate to severe asthma who have elevated sputum neutrophils.

• IRAS ID

  15221

• Contact name

  Ian Pavord

• Sponsor organisation

  University of Strathclyde.

• Eudract number

  2008-007244-33

• 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. People with asthma get attacks of wheezing and breathlessness, caused by inflammation and narrowing of the small tubes (bronchioles) that carry air in and out of the lungs. Attacks are mainly caused by allergens (such as house-dust mite, animal fur, pollen), infection, exercise or emotion.Existing treatments for asthma do not fully control the symptoms in all patients with severe asthma. We hope that the study medicine will block the production of substances thought to cause inflammation of the airways, and be a useful addition to current treatments for people with severe asthma.In this study, We'll test the safety, blood levels and effects of the study medicine. To test the effects of the study medicine on the lungs, participants will inhale a fine mist of a salty solution, and cough up secretions from their lungs, before, and on several occasions after, treatment. We'll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine. Up to 50 patients with moderate to severe asthma, aged 18-65, will take 12 daily doses of study medicine. Half the participants will take dummy medicine instead of the study medicine - neither they nor we will know which one they??re taking. Participants will take up to 10 weeks to finish the study. They'll make 6 outpatient visits.Participants might notice an improvement in their asthma during the study. But they won??t get any long-term benefit from the short course of study medicine that They'll receive in this study. A pharmaceutical company, GlaxoSmithKline, is funding the study.The study will take place in hospitals in Leicester and Glasgow.

• REC name

  London - Central Research Ethics Committee

• REC reference

  09/H0718/7

• Date of REC Opinion

  8 Apr 2009

• REC opinion

  Further Information Favourable Opinion