Date: 2011-09-27
Type of information:
phase: 3
Announcement: results
Company: Almirall (Spain)
Product: aclidinium bromide
Action mechanism:
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country:
Trial details:
Latest
news: Almirall has announced results from the ATTAIN study at the Annual Congress of the European Respiratory Society (ERS) showing the safety and efficacy of aclidinium bromide for the treatment of COPD. The findings demonstrate that from the first dose, aclidinium bromide 200 ?g and 400 ?g twice daily significantly improved airflow limitation measure by forced expiratory volume in one second (FEV1), compared to placebo.The ATTAIN study lasted for six months and involved 828 patients with moderate to severe COPD. The data presented at ERS also confirm that aclidinium bromide has a favourable safety and tolerability profile at both the 200 ?g and 400 ?g doses.In particular, the data demonstrate a low incidence of anticholinergic adverse events across all treatment groups.
Treatment with aclidinium provided 24 hour symptom relief according to the newly presented ATTAIN data which shows improvement in COPD symptoms, as assessed by the Transitional Dyspnoea Index (TDI) and the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT). Along with improved lung function and reduction of symptoms, patients treated with aclidinium in the ATTAIN study also experienced improvements in markers of quality of life as measured by the St George’s Respiratory Questionnaire (SGRQ) and the EuroQuol questionnaire (EQ-5D).
The study authors noted that this may translate into noticeable benefit for patients in routine practice. In particular, with aclidinium 400 ?g, the improvement in the SGRQ was seen as early as 12 weeks after the start of treatment. Aclidinium bromide 400 ?g also significantly improved EQ-5D (weighted index and VAS score) at week 24, compared with placebo.3
