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STOCKHOLM, Sweden, Sept. 18 /PRNewswire-FirstCall/ -- Forest Laboratories (NYSE: FRX) announced today that single doses of inhaled aclidinium produced a significant bronchodilatory response in 17 patients with COPD according to results of a phase IIa trial presented today at the European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
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Results of the study showed that mean FEV1 and FVC values - important measures of lung function - were significantly increased with all studied doses of aclidinium over a 24-hour time period, as compared to placebo. Onset of significant bronchodilation was observed as early as 15 minutes after aclidinium treatment and this effect was sustained for at least 24 hours. Forest licensed aclidinium, currently in phase III clinical trials in COPD, from Spanish pharmaceutical company, Almirall.
Aclidinium was well-tolerated during the phase IIa trial and no patients withdrew from the study because of adverse events. The majority of adverse events reported were mild to moderate in intensity. The most frequent drug- related adverse event observed was headache, which occurred after both placebo and aclidinium treatment and was not dose-related. Single doses of aclidinium did not result in any clinically significant adverse effect on vital signs, heart function (as assessed by 12-lead ECG) or laboratory data.
"Given the increasing disease burden of COPD in the US, there is a need
for new treatment options for patients suffering from this debilitating
disease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
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