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Forest Laboratories and Almirall report positive COPD trial data
Forest Laboratories and Almirall have reported encouraging clinical data from the second pivotal phase III trial of their new inhaler-based treatment for chronic obstructive pulmonary disease (COPD).
Top-line results from the Augment COPD trial showed that the investigational fixed dose combination of aclidinium bromide and formoterol fumarate demonstrated consistent and statistically significant lung function improvements among patients.
Moreover, positive outcomes in terms of breathlessness and quality of life enhancements were also recorded.
Data from this trial will support the companies' plans to file for European and US regulatory approval of the new therapy in the fourth quarter of 2013.
Dr Marco Taglietti, president of the Forest Research Institute, said this success "supports the potential of aclidinium/formoterol as a new treatment option for COPD patients who could benefit from the enhanced bronchodilation of two complementary, proven therapies".
This follows on from similarly positive findings from the Acliform/COPD trial published by the two companies last month.
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