PT  - JOURNAL ARTICLE
AU  - Anthony D'Urzo
AU  - Stephen Rennard
AU  - Edward Kerwin
AU  - Victor Mergel
AU  - Thomas He
AU  - Anne Leselbaum
AU  - Cynthia Caracta
TI  - One-year efficacy of aclidinium/formoterol fixed-dose combination in COPD patients: The AUGMENT COPD study
DP  - 2014 Sep 01
TA  - European Respiratory Journal
PG  - P286
VI  - 44
IP  - Suppl 58
4099  - http://erj.ersjournals.com/content/44/Suppl_58/P286.short
4100  - http://erj.ersjournals.com/content/44/Suppl_58/P286.full
SO  - Eur Respir J2014 Sep 01; 44
AB  - BACKGROUND: Treatment with either aclidinium (ACL) or formoterol (FOR) improves lung function and reduces symptoms in COPD patientsAIM: To assess the efficacy of fixed-dose combinations (FDC) of ACL bromide/FOR fumarate in COPD patients.METHODS: Patients were randomized to twice-daily ACL/FOR 400µg/12µg (FDC12), 400µg/6µg (FDC6), ACL 400µg, FOR 12µg, or placebo (PBO). Following a 24-week lead-in, consenting patients continued double-blind treatment for 28 more weeks (52 weeks total). Lung function (1-hr postdose FEV1 and trough FEV1), transition dyspnea index (TDI) focal score, and % TDI responders (patients with ≥1 unit improvement from baseline) are presented.RESULTS: Statistically significant improvements from baseline in 1-hr postdose FEV1 and trough FEV1 were seen for both FDCs vs placebo throughout 52 weeks (Table). At week 52, clinically meaningful improvements in TDI focal score and significantly greater percentages of TDI responders were seen with both FDCs vs PBO. Numerical improvements in TDI were generally greater with FDC12 vs FDC6. Statistically significant improvements from baseline in 1-hour postdose (day 1, week 52) and trough FEV1 (day 4) were observed with both FDCs vs either monotherapy.CONCLUSIONS: One-year treatment with aclidinium/formoterol FDCsresulted in statistically significant and clinically meaningful improvements in bronchodilation and dyspnea in COPD patients.