Almirall has published full results from the ATTAIN (Aclidinium To Treat Airway obstruction In COPD patieNts) study in The European Respiratory Journal (ERJ). ATTAIN was a six-month double-blind placebo-controlled study that compared two doses of inhaled aclidinium (200μg and 400μg twice daily) to placebo in patients with COPD. According to the company the 400 µg dose produced improvements in trough FEV1 from 105 to 140 mL, and the lower dose also produced significant improvement. In addition, both doses produced “large improvement” on health scores over the 24-week study as measured by the St George’s Respiratory Questionnaire (SGRQ). Both doses also reduced exacerbations.
The ATTAIN lead investigator, Professor Paul Jones of St George’s, University of London, commented, “COPD is an increasing public health problem which has a very big impact on patients’ lives. As a result, there is a real need for effective and well tolerated treatment options. The findings of ATTAIN are very encouraging and we would expect that improvements seen in health status and symptoms within the trial will translate into noticeable benefits for patients in every-day’s practice.”
An FDA advisory committee recommended approval of aclidinium bromide in February of this year, and the company says it expects responses to its applications from both the FDA and the EMA by the end of 2012.
Read the Almirall press release.
Read the ERJ abstract.
