A fixed-dose combination (FDC) of aclidinium and formoterol improves lung function and is well tolerated over a year in patients with moderate to severe COPD, according to studies presented at the American Thoracic Society’s annual congress.

Initially, patients received either placebo or one of the following drugs twice daily for 24 weeks:

• Aclidinium 400mcg plus formoterol 12mcg (FDC 400/12)
• Aclidinium 400mcg plus formoterol 6mcg (FDC 400/6)
• Aclidinium 400mcg
• Formoterol 12mcg.

Patients (n=1,668) could then elect to continue double-blind treatment for another 28 weeks.

The forced expiratory volume in one second (FEV₁) measured one hour after treatment improved from baseline with both doses of the FDC as well as aclidinium and formoterol monotherapies compared to placebo from day one to week 52. Trough FEV₁ improved from baseline compared to placebo at all visits throughout the study with all treatments. However, compared with placebo, only FDC 400/12 showed statistically significant and clinically meaningful improvements throughout the study. Both FDCs were well tolerated for up to a year with similar safety profiles to the monotherapies and placebo.

Another study compared 385 patients with moderate to severe COPD taking FDC 400/12 with 196 who received formoterol. A week after the first dose, trough FEV1 improved by 87ml with FDC 400/12 (137ml) more than with formoterol (50ml). This improvement was statistically significant and was maintained until the end of the 52-week study, when the difference was 82ml.

FDC and formoterol reduced average daily rescue medication use compared with baseline (1.8 and 1.6 puffs respectively). The FDC was well tolerated with a similar safety profile to formoterol alone.