Comparing Neolab FP/SM and Seretide

• Research type

  Research Study

• Full title

  A randomized, single blind double dummy, single center, crossover study to compare the systemic bioavailability of Fluticasone and Salmeterol in the combination Fluticasone/ Salmeterol delivered by a generic HFA pMDI (test) with the innovator Fluticasone/ Salmeterol HFA pMDI (reference, Seretide Evohaler TM) in healthy volunteers.

• Sponsor organisation

  Neolab Ltd

• Eudract number

  2008-006864-12

• Research summary

  Asthma is a chronic disease, which means that it cannot be cured, but we can use inhalers to control the symptoms. The airway muscle spasm in asthma is treated using short-acting beta-2 agonists, which work by relaxing the airway muscle. The inflammation is treated with inhaled steroids. Current guidelines recommend that if patients?? asthma is not controlled on normal doses of steroids, a long acting version of the beta-2 agonists should be added in. This is often given combined with inhaled steroid in a single combination inhaler (FP/SM). This study is being carried out on behalf of Neolab Ltd as part of their commercial development of a new type of generic combination inhaler (Neolab FP/SM) to see if it is as effective, safe and well tolerated as one which is currently used in the UK (Seretide (FP/SM), Allen and Hanbury??s Ltd, UK). Studies carried out so far have shown both formulations of FP/SM to be equivalent on a 1:1 microgram basis.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  08/S1401/138

• Date of REC Opinion

  15 Jan 2009

• REC opinion

  Further Information Favourable Opinion