Effect of GSK2190915 on sputum neutrophils in asthmatics; ver.A
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, cross-over study to evaluate the effect of treatment with repeat dose GSK2190915 as an add-on to current therapy on the percentage of neutrophils in induced sputum in asthmatic patients with elevated sputum neutrophils
IRAS ID
76834
Contact name
Neil C. Thomson
Contact email
Sponsor organisation
GlaxoSmithKline Research and Development Ltd
Eudract number
2010-024436-41
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
People with asthma get attacks of wheezing and breathlessness, caused by inflammation and narrowing of the small tubes that carry air in and out of the lungs. Neutrophils (a type of white blood cell) in the lung are thought to play a role in more severe/persistent asthma. In the lungs of asthmatic people, neutrophils can cause the production of substances that cause airway damage. We hope that the study medicine will block the number of neutrophils in the airways and therefore reduce airways damage. 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 20 patients with asthma will take part in this study. This is a placebo controlled study, with two treatments, one active and one placebo. Every participant takes both active and placebo treatments. One dose of study drug or placebo will be given every day for a minimum of 13 days and up to a maximum of 16 days in each treatment period. Participants will take up to 16 weeks to finish the study and make 12 outpatient visits. Participants may notice an improvement in their asthma but won??t get any long-term benefit from the short course of study medicine that they??ll receive. A pharmaceutical company, GlaxoSmithKline, is funding the study. The study will take place in a hospital in Glasgow.
REC name
West of Scotland REC 1
REC reference
11/AL/0159
Date of REC Opinion
7 Apr 2011
REC opinion
Favourable Opinion