19 Sep 2007 03:00 AM
Study Results For Aclidinium Bromide, A Novel Anticholinergic, Presented At European Respiratory Society Annual Congress
Forest
Laboratories (NYSE: FRX) announced 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)
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 Operating Officer. "These phase II data reinforce our belief that aclidinium has the potential to be a significant addition to the existing armamentarium of COPD treatments."
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…
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 Operating Officer. "These phase II data reinforce our belief that aclidinium has the potential to be a significant addition to the existing armamentarium of COPD treatments."
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…
