Effect of 8 and 12 weeks' once-daily tiotropium and olodaterol, alone and combined with exercise training, on exercise endurance during walking in patients with COPD

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Introduction: Physical deconditioning is common in patients with COPD, limiting exercise tolerance. Aim: PHYSACTO ® (NCT02085161) tested the effects of bronchodilators alone or with exercise training (ExT), combined with a standardised physical activity self-management behaviour-modification (BM) programme, on exercise endurance time (EET) in patients with COPD. Methods: A 12-week (wk) randomised, partially double-blind, placebo (P)-controlled, parallel-group trial at 34 sites in Australia, New Zealand, USA, Canada and Europe. Interventions (all with 12-wk BM): P; tiotropium (T) 5 µg; T + olodaterol (T+O) 5/5 µg; T+O 5/5 µg with 8 wks9 ExT (T+O 5/5 µg + ExT). EET (log transformed) during an endurance shuttle-walk test (ESWT) to symptom limitation was assessed after 8 wks (primary end point) and 12 wks. Results: 303 patients (200 men) were randomised and treated (full analysis set n=274). Mean post-bronchodilator FEV 1 was 1.59 L (56.7% predicted). EET significantly increased with T+O 5/5 µg and T+O 5/5 µg + ExT versus P at 8 wks (Fig); 13 patients reached test termination criteria (20 mins) without symptom limitation (P, n=0; T, n=3; T+O, n=2; T+O + ExT, n=8) at 8 wks. No safety concerns were identified. Conclusions: T+O 5/5 µg, alone and combined with ExT, improved EET during ESWT compared to P in moderate to severe COPD. Funding: Boehringer Ingelheim.