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Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Date:9/2/2008

benefit possible from dosing alternatives", commented Per-Olof Andersson, Executive Director R&D of Almirall.

Aclidinium significantly improved the percentage of patients showing a clinically relevant improvement (greater than or equal to 4 points) in health-related quality of life compared with placebo in the ACCLAIM/COPD I study (week 52; p-value=0.025) as measured by the St. George's Respiratory Questionnaire (SGRQ). ACCLAIM/COPD II did not reach statistical significance for SGRQ at week 52 (p-value=0.074), however the study showed statistical significance at all previous time-points (p-value<0.001). Pooled analysis of both studies showed a statistically significantly higher percentage of patients improving greater than or equal to 4 units in the SGRQ at week 52 (p- value=0.04).

Secondary endpoint results demonstrated that aclidinium significantly delayed the time to the first moderate to severe exacerbation in patients with COPD in ACCLAIM/COPD II (p-value=0.01), whereas results were not significant in ACCLAIM/COPD I. In the pooled analysis of both studies, there was a positive trend in delaying the time to first moderate or severe exacerbation (p-value=0.054).

"Forest is pleased with the results of these studies and remains committed with Almirall to the development of aclidinium bromide in COPD", said Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories.

ACCLAIM/COPD study design and results

Two double-blind, multicenter, parallel-group, placebo-controlled Phase III studies were conducted, one in Europe (ACCLAIM/COPD I) and the other primarily in North America (ACCLAIM/COPD II), to evaluate the efficacy and safety of inhaled aclidinium administered once daily. A total of 1,647 patients, across 23 countries participated in these trials. Patients had a diagnosis of moderate to severe COPD and were a minimum of 40 years of age with at least a 10 pack-year smoking history. The mean FEV1 values at baseline w
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SOURCE Forest Laboratories, Inc.
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