Almirall, S.A. and Forest Laboratories Inc. (FRX) announced positive topline results from AUGMENT/COPD, the second six-month pivotal phase III clinical trial evaluating the efficacy and safety of investigational fixed dose combinations of aclidinium bromide or LAMA and formoterol fumarate or LABA for the treatment of Chronic Obstructive Pulmonary Disease or COPD, delivered in the Pressair inhaler (Genuair outside the USA).
The 400/12mcg combination of aclidinium/formoterol given twice daily demonstrated statistically significant improvements in change from baseline for the co-primary endpoints of Forced Expiratory Volume (FEV1) at 1 hour post-dose versus aclidinium 400mcg (p<0.0001), and="" morning="" predose="" trough="" fev1="" versus="" formoterol="" 12mcg="" at="" week="" 24=""><0.05). the="" 400/6mcg="" combination="" demonstrated="" statistically="" significant="" improvements="" in="" (fev1)="" at="" 1="" hour="" post-dose="" versus="" aclidinium="" 400mcg=""><0.0001). for="" the="" change="" from="" baseline="" in="" morning="" pre-dose="" trough="" fev1,="" the="" 400/6mcg="" combination="" did="" not="" reach="" significance="" versus="" formoterol="" 12mcg="" at="" week="" 24="" (p="">0.05).
Both combinations of aclidinium/formoterol (400/12mcg and 400/6mcg) provided statistically significant improvements versus placebo in the above two comparisons (both p<0.0001).>
The positive results of the aclidinium/formoterol 400/12mcg combination in this study are consistent with the statistically significant improvement in lung function demonstrated by aclidinium/formoterol 400/12mcg in the previously completed ACLIFORM/COPD Phase III study. In both studies, the 400/12mcg dose successfully met the required regulatory "Combination Rule" for testing two or more drugs combined in a single dosage form.
The companies said they have planned Regulatory filings in the USA and Europe in the fourth-quarter 2013.
AUGMENT (Aclidinium/formoterol FUmurate Combination for InvestiGative use in the TreatMENT of Moderate to Severe COPD) was a 24-week randomized double-blind trial evaluating the 400/12mcg and 400/6mcg fixed dose combinations of aclidinium bromide/formoterol fumarate compared with aclidinium bromide 400mcg, formoterol fumarate 12mcg and placebo administered BID through the Pressair inhaler (Genuair outside the USA) in 1,692 patients with moderate to severe COPD in the USA, Australia and New Zealand.
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