Almirall and Forest Laboratories have reported positive results from the Phase III study of aclidinium bromide and the Phase IIb studies of fixed dose combination of aclidinium bromide / formoterol, in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
The Phase III study was designed to compare the efficacy and safety of inhaled aclidinium bromide 200 micrograms and 400 micrograms twice daily versus placebo in 828 patients with moderate to severe COPD.
Aclidinium 200 micrograms and 400 micrograms demonstrated statistically significant increases from baseline in morning pre-dose (trough) FEV1 versus placebo at week 24 – which was the primary endpoint for Europe, and at week 12 – which was the primary endpoint for the US.
All secondary endpoints produced statistically significant differences versus placebo for both doses, and the endpoints included peak FEV1, the percentage of patients with improved health status.
Regulatory filings in Europe and the US for aclidinium bromide monotherapy are expected in mid 2011.
The company also successfully completed two Phase IIb dose-ranging studies comparing fixed-dose combinations (aclidinium bromide / formoterol) to aclidinium bromide alone, formoterol alone and placebo in patients with moderate to severe COPD.
In both the studies, fixed-dose combination showed statistically significant differences on the primary endpoint versus placebo.
The fixed-dose combination provided improved bronchodilation compared to aclidinium and formoterol alone.
The company plans to initiate Phase III of the fixed dose combination in the second half of 2011.