PT  - JOURNAL ARTICLE
AU  - Donald Tashkin
AU  - Arthur Gelb
AU  - Barry Make
AU  - Xiaoyun Zhong
AU  - Esther Garcia Gil
AU  - Cynthia Caracta
TI  - Long-term efficacy of twice-daily aclidinium bromide in COPD patients: A one-year study
DP  - 2012 Sep 01
TA  - European Respiratory Journal
PG  - P2893
VI  - 40
IP  - Suppl 56
4099  - http://erj.ersjournals.com/content/40/Suppl_56/P2893.short
4100  - http://erj.ersjournals.com/content/40/Suppl_56/P2893.full
SO  - Eur Respir J2012 Sep 01; 40
AB  - INTRODUCTION:Aclidinium bromide is a long-acting muscarinic antagonist currently under investigation for the long-term maintenance treatment of COPD. In this study, the long-term efficacy and safety of twice-daily (BID) aclidinium 200 µg and 400 µg in moderate-to-severe COPD patients were assessed. The efficacy results are reported here.METHODS:Patients were randomized (1:1) to receive aclidinium 200 µg or 400 µg BID in a double-blind manner. The primary endpoint was change from baseline to Week 52 in trough FEV1. Other efficacy parameters included change from baseline to Week 52 in peak FEV1, trough and peak FEV1 by study visit, normalized FEV1AUC0-3, and change from baseline to Week 52 in SGRQ and EuroQol scores.RESULTS:A total of 605 patients were randomized to this study. Both aclidinium 200 µg and 400 µg BID resulted in improvements from baseline to Week 52 in trough and peak FEV1 (Table), with numerically larger increases seen with the 400 µg dose. At study end, change from baseline in normalized AUC0-3 FEV1 was also improved for both groups, with greater improvements seen with the higher aclidinium dose (Table). Both treatment groups showed clinically significant improvements in SGRQ Total score and improvements in EuroQoL parameters from baseline to Week 52 (Table).CONCLUSIONS:Treatment with aclidinium 200 µg or 400 µg BID results in benefits in lung function and health status in COPD patients over 1 year.