Almirall has presented a number of posters at the 2011 Annual Congress of the European Respiratory Society (ERS), including, for the first time, full data from the six-month Phase 3 ATTAIN study of its aclidinium bromide dry powder inhaler for the treatment of moderate-to-severe COPD. The data show that twice-daily doses of either 200 μg or 400 μg of aclidinium bromide, a long-acting antimuscarinic, produced significant improvement in FEV1 compared to placebo from the first dose.
The ATTAIN data show improvement in COPD symptoms and quality of life as assessed by the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT), Transitional Dyspnoea Index (TDI), the St George’s Respiratory Questionnaire (SGRQ), and the EuroQuol questionnaire (EQ-5D).
Professor Paul Jones of St George’s Hospital, University of London, commented, “COPD can be a debilitating disease due to a number of symptoms, particularly breathlessness. This has a large impact on the patients’ quality of life. These findings from the ATTAIN programme are very promising as they demonstrate that aclidinium bromide can improve breathlessness and reduce the impact of symptoms throughout the day, as well as improving lung function.”
“There is an unmet need for new therapeutic options to improve the health and quality of life of patients living with COPD. Based on the findings of the comprehensive ATTAIN programme, aclidinium bromide has shown great potential for addressing this need by offering 24 hour improvement in symptoms along with improved health status and lung function,” suggested Bertil Lindmark, Almirall’s Chief Scientific Officer.
Almirall’s aclidinium bromide product is delivered using its Genuair dry powder inhaler and will be marketed as Eklira if approved. The company has already submitted an NDA in the US and an MAA in Europe for the product.
Read the Almirall press release.