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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.