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Methodology

The phase IIa study of aclidinium was a two-center, double-blind, randomized, ascending single-dose, placebo-controlled, cross-over trial which enrolled 17 patients with moderate to severe COPD. Treatment was with one of three doses of aclidinium (100 micrograms, 300 micrograms or 900 micrograms) or placebo-administered via dry-powder inhaler. The study's primary outcome measure was area under the normalized curve (AUC) of FEV1 over a 24-hour time period.

Findings of a phase I single-dose study, also presented at ERS 2007, demonstrate the bronchodilatory effects of aclidinium.(2) In the phase I study, in 12 healthy volunteers, bronchoconstriction was induced with methacholine challenge and then treated with one of three doses of aclidinium. Aclidinium proved superior to placebo in improving specific airway conductance. Aclidinium also provided statistically significant and sustained protection against methacholine-induced airway constriction over 24 hours. Aclidinium was well-tolerated throughout the trial. Headache was reported by two subjects and one subject experienced a serious adverse event which was not considered to be related to study drug.

Results of preclinical studies also presented at the congress show aclidinium's selectivity, long duration of action and rapid clearance from the plasma.(3,4) When compared to other bronchodilatory agents in vitro, aclidinium demonstrated potent anticholinergic activity comparable to both tiotropium and ipratropium, but with a faster onset of action than tiotropium and a significantly longer duration of action versus ipratropium, allowing for 24- hour duration of action.(4)

Notes:

FEV1 - Forced expiratory volume at 1 second

FVC - Forced vital capacity

ECG - Electrocardiogram

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