Superiority of fluticasone salmeterol over double dose fluticasone

• Research type

  Research Study

• Full title

  A randomized, double- blind, double- dummy, cross- over study to demonstrate superiority of Fluticasone/Salmeterol pMDI over double the dose Fluticasone pMDI on methacholine hyper-reactivity in patients with persistent mild to moderate asthma.

• Sponsor organisation

  University of Dundee

• Eudract number

  2008-001027-59

• Research summary

  In asthma the airways areinflamed (swollen). This causes muscle spasm in the airway. This is treatedwith reliever inhalers like salbutamol (ventolin) which relax these airwaymuscles. The inflammation is treated with preventors (steroid inhalers).Guidelines say if a patients?? asthma is not controlled on medium doses ofsteroids, a long acting version of salbutamol should be added (usually as acombination inhaler with the steroid). Studies have shown that combinationinhalers are good at helping symptoms and breathing tests, but they have notstudied inflammation in detail. We know inhaled steroids don't work as well insmokers compared to non-smokers. However, a recent study on smokers showed thatcombination inhalers worked better than steroid alone. We want to find out whatis more important: treating the inflammation (with steroid) or treating theairway muscle spasm (with the long acting salbutamol). We also want to see ifit is different in smokers and non-smokers.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  08/S1402/48

• Date of REC Opinion

  21 Oct 2008

• REC opinion

  Further Information Favourable Opinion