Almirall Launches Phase III Clinical Programme for COPD Therapy

The Phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies.

Spanish pharmaceutical company Almirall, S.A., together with its US partner Forest, initiated a Phase III clinical programme of the fixed dose combination (FDC) of aclidinium bromide and formoterol fumarate twice daily (BID) delivered in the Genuair? inhaler, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

The Phase III programme involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies -one conducted mainly in Europe and another in North America- evaluating the efficacy and safety of the FDC of aclidinium plus formoterol during 24 weeks, as well as a long-term safety study of 52 weeks which is also performed in North America.

Protocols of these clinical trials have been desi