Background: The novel LABA olodaterol (O) has 24-h bronchodilator activity. Objective: To evaluate the symptomatic benefit of O QD in patients (pts) with GOLD 2-4 COPD. Methods: In replicate, randomized, double-blind, placebo (P)-controlled, parallel-group studies, pts with post-bronchodilator FEV1 < 80% predicted normal and FEV1/FVC < 70% received O (5 or 10 (mu)g) QD via Respimat(registered trademark), formoterol (F; 12 (mu)g) BID via Aerolizer(registered trademark) or P for 48 weeks (wks; Study A: NCT00793624; Study B: NCT00796653). Pts continued to receive usual care background COPD maintenance therapy, including SAMA, LAMA, ICS and xanthines. In addition to FEV1-based primary end points, TDI and SGRQ after 24 wks were identified as co-primary and key secondary symptomatic end points, respectively. Results: 904 (Study A) and 934 (Study B) pts were treated. In the primary analysis using a mixed model for repeated measures (MMRM; combined dataset), there was no significant difference in TDI focal score after 24 wks for O or F vs P. A post hoc analysis using pattern mixture modelling (PMM) to account for discontinued pts demonstrated statistical significance for O vs P. There were significant improvements in SGRQ total score with O, but not F, vs P after 24 wks using MMRM and PMM. Conclusions: Lung function improvements with O QD translated into symptomatic benefit in COPD pts receiving usual care background therapy. (Table Presented).
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