Flutiform in COPD Misses Primary Endpoint in Phase III Trial

A Phase III trial of the flutiform inhaler did not meet its primary endpoint of demonstrating statistically significant superiority in the reduction of annualized rates of moderate and severe exacerbations of chronic obstructive pulmonary disease, when compared to mono-component long-acting β2-agonist treatment alone.

The goal of the study, sponsored by Mundipharma, was to support an expansion of flutiform’s indication to include COPD in the European Union. Flutiform (fluticasone/formoterol) is approved in Europe for the regular treatment of asthma.