Flutiform (fluticasone plus formoterol) fails Phase III trial for treatment of COPD.- Vectura + Mundi

Vectura Group plc has been informed by its partner Mundipharma that its Phase III trial of Flutiform (fluticasone plus formoterol) did not meet the primary endpoint of demonstrating statistically significant superiority in the reduction of annualised rates of moderate and severe COPD exacerbations when compared to mono-component LABA treatment alone. Mundipharma carried out this Phase III study to support a filing to expand the approved indication for the regular treatment of asthma of flutiform in Europe to include chronic obstructive pulmonary disease (COPD).

Mundipharma is currently undertaking an analysis of the trial’s other endpoints but has indicated that the primary endpoint result will not allow it to make a regulatory filing for the COPD indication in Europe. The Phase III trial was an international double blind study with 1,767 randomised patients in 16 countries. Patients either received flutiform 250/10µg (2 puffs twice per day), flutiform® 125/5µg (2 puffs twice per day) or formoterol fumarate dihydrate 12µg (1 puff twice per day) for 52 weeks. The primary endpoint compared the annualised rate of moderate and severe COPD exacerbations of patients treated with flutiform 250/10µg (2 puffs twice per day) against those treated with formoterol fumarate dihydrate 12µg (1 puff twice per day).