Flutiform trial for COPD initiated in Europe

UK drug delivery specialist Skyepharma (LSE: SKP) and privately-held Swiss drugmaker Mundipharma, which is responsible for the on-going development of Flutiform (fluticasone propionate/formoterol fumarate) in Europe and most territories outside the Americas and Japan, announced that the latter has commenced an international clinical trial of Flutiform for the treatment of chronic obstructive pulmonary disease (COPD).

Flutiform is a single aerosol inhaler incorporating SkyePharma’s proprietary SkyeDry technology. The news pushed Skyepharma’s shares up 5% to 85.58 pence in mid-morning trading today.

The study is a randomized, double-blind triak comparing Flutiform 250/10mcg and Flutiform 125/5mcg with formoterol 12mcg in subjects with COPD. The primary endpoint of the study is to compare the annualized rate of moderate and severe COPD exacerbations during a 52-week treatment period. The aim of the study is to demonstrate the superiority of the efficacy of Flutiform over formoterol in a pressurized metered dose inhaler (pMDI). The planned number of subjects in the trials is 1,530. The cost of these COPD studies will be borne by Mundipharma.