BARCELONA and NEW YORK, January 4, 2011 /PRNewswire/ –
– ATTAIN results confirm clinically significant bronchodilation and improvement ofsymptoms in COPD patients treated with aclidinium bromide twice daily – Regulatory filings in Europe and USA for aclidinium bromide monotherapy are planned for mid 2011 – Positive results of two Phase IIb studies with the fixed dose combination of aclidinium bromide and formoterol will enable Phase III to start in second half 2011
Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. today announced positive top-line results of ATTAIN, a six month double-blind placebo-controlled pivotal Phase III study comparing the efficacy and safety of inhaled aclidinium bromide 200 micrograms and 400 micrograms twice daily (BID) versus placebo, in 828 patients with moderate to severe COPD.
Aclidinium 200 micrograms and 400 micrograms produced statistically significant increases from baseline in morning pre-dose (trough) FEV1 versus placebo at week 24 (99mL and 128mL, respectively; p