Effects of smoking on steroid treatment of mild asthma; version 1

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo-controlled three-way crossover study in mild asthmatics to evaluate the effect of smoking status on the attenuation by inhaled corticosteroids of the allergen-induced asthmatic response

• IRAS ID

  73986

• Contact name

  Malcolm Boyce

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  N/A

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  People with asthma suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become inflamed and narrow. Steroids reduce the inflammation, and are commonly used to control asthma, but they don??t work well in some asthmatics, particularly those who smoke. We??re doing this study to find out more about why smokers with asthma don??t benefit from steroid treatment. In this study, We'll test the effect of Flixotide (fluticasone propionate), a steroid widely used to treat asthma, in smokers and non-smokers with mild asthma.We'll recruit about 20 smokers and about 20 non-smokers, aged 18-55 years. Participants will take each of the following treatments:* 100 micrograms Flixotide twice daily for 7 days;* 500 micrograms Flixotide twice daily for 7 days; and* placebo (dummy medicine) twice daily for 7 days.Participants?? treatment periods will be separated by intervals of 14 days. A computer will decide in which order participants take the treatments.To test the effects of Flixotide, We'll measure participants?? responses to * an inhaled allergen to which they??re sensitive; and* methacholine ?? a substance that narrows the bronchioles in patients with asthma. We'll take samples of blood, urine and sputum (secretions coughed up from the lungs) to measure substances linked to inflammation. Participants will attend the ward on 12 occasions during the study, including up to 4 overnight stays. They??ll take at least 11 weeks to finish the study.This study will take place in 2 centres: 1 in the UK and 1 in Belgium. The units will recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and via the centres?? websites.A pharmaceutical company, GlaxoSmithKline, is funding the study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/0193

• Date of REC Opinion

  18 Apr 2011

• REC opinion

  Further Information Favourable Opinion