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
23. Februar 2017 (online)
Physical deconditioning is common in patients with COPD, limiting exercise tolerance.
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.
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 wks' 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.
303 patients (200 men) were randomised and treated (full analysis set n = 274). Mean post-bronchodilator FEV1 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.
T+O 5/5 µg, alone and combined with ExT, improved EET during ESWT compared to P in moderate to severe COPD.
Content already presented at ERS congress 2016