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Results of the study showed that mean FEV1 and FVC values - importantmeasures of lung function - were significantly increased with all studieddoses of aclidinium over a 24-hour time period, as compared to placebo. Onsetof significant bronchodilation was observed as early as 15 minutes afteraclidinium 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.
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Aclidinium was well-tolerated during the phase IIa trial and no patientswithdrew from the study because of adverse events. The majority of adverseevents reported were mild to moderate in intensity. The most frequent drug-related adverse event observed was headache, which occurred after both placeboand aclidinium treatment and was not dose-related. Single doses of aclidiniumdid 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 needfor new treatment options for patients suffering from this debilitatingdisease," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief OperatingOfficer. "These phase II data reinforce our belief that aclidinium has thepotential to be a significant addition to the existing armamentarium of COPDtreatments."
Methodology
The phase IIa study of aclidinium was a two-center, double-blind,randomized, ascending single-dose, placebo-controlled, cross-over trial whichenrolled 17 patients with moderate to severe COPD. Treatment was with one ofthree doses of aclidinium (100 micrograms, 300 micrograms or 900 micrograms)or placebo-administered via dry-powder inhaler. The study's primary outcomemeasure was area under the normalized curve (AUC) of FEV1 over a 24-hour timeperiod.
Findings of a phase I single-dose study, also presented at ERS 2007,demonstrate the bronchodilatory effects of aclidinium.(2) In the phase Istudy, in 12 healthy volunteers, bronchoconstriction was induced withmethacholine challenge and then treated with one of three doses of aclidinium.Aclidinium proved superior to placebo in improving specific airwayconductance. Aclidinium also provided statistically significant and sustainedprotection against methacholine-induced airway constriction over 24 hours.Aclidinium was well-tolerated throughout the trial. Headache was reported bytwo subjects and one subject experienced a serious adverse event which was notconsidered to be related to study drug.
Results of preclinical studies also presented at the congress showaclidinium's selectivity, long duration of action and rapid clearance from theplasma.(3,4) When compared to other bronchodilatory agents in vitro,aclidinium demonstrated potent anticholinergic activity comparable to bothtiotropium and ipratropium, but with a faster onset of action than tiotropiumand a significantly longer duration of action versus ipratropium, allowing for24- hour duration of action.(4)
About COPD
COPD is a preventable and treatable lung disease characterized by chronicairflow limitation that is not fully reversible.(5) COPD is a leading cause ofdeath, illness, and disability in the United States, with an estimated 10million to 24 million adults in the US living with COPD.(6)
About Aclidinium Bromide
Aclidinium bromide is a novel inhaled anticholinergic bronchodilator thatis currently in phase III clinic
