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Almirall and Forest complete Phase III COPD studies

This article was originally published in Scrip

Executive Summary

The Spanish company Almiralland US-based Forest Laboratories have announced the completion of two pivotal Phase III studies designed to assess the efficacy and safety of aclidinium bromide – an anticholinergic bronchodilator – in moderate to severe chronic obstructive pulmonary disease (COPD) patients. Preliminary top-line results are expected later this year. Both trials, one conducted in Europe and the other in North America, were double-blind, multi-centred, parallel-group and placebo-controlled. Patients were aged at least 40, and had a 10 pack year smoking history. The primary end point of both trials is pre-dose forced expiratory volume in one second (a common measure of pulmonary function) versus placebo. Almirall and Forest are co-developing aclidinium bromide; the latter is to market the product in the US while Almirall retains the rights for the rest of the world.

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