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Home Industry News Almirall and Forest complete phase III COPD studies

Almirall and Forest complete phase III COPD studies

10th July 2008

Laboratorios Almirall and Forest Laboratories have announced the final patients have finished treatment in their phase III Acclaim/COPD I&II (aclidinium clinical trial assessing efficacy and safety in moderate to severe COPD patients) trials.

The programme tested aclidinium bromide for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

Two double-blind, parallel-group, multi-centre, placebo controlled trails were conducted in Europe and the US to look at the usefulness and safety of aclidinium.

Patients, who were at least 40-years-old with a minimum of a ten pack-year smoking history, received either aclidimium or placebo over the course of a year.

Dr Jorge Gallardo, chairman and chief executive at Almirall said: “We are very pleased that the Acclaim/COPD studies have closed, and anticipate the results later this year.

“COPD is a very serious disease and we hope that aclidinium bromide will be a valuable treatment option for COPD patients.”

Phase II clinical trials showed aclidinium bromide resulted in a significant sustained bronchodilation over 24-hours, as well as being tolerated well.

The onset of bronchodilation was shown to emerge as quickly as 15 minutes after aclidinium treatment.

Meanwhile, Phase I studies demonstrated aclidinium bromide was better than the placebo in improving specific airway conductance.

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