Abstract
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, randomised, 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 µg) QD via Respimat®, formoterol (F; 12 μg) BID via Aerolizer® 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.
Funding: Boehringer Ingelheim.
- © 2013 ERS