Rationale Physical deconditioning is common in patients with chronic obstructive pulmonary disease (COPD), limiting exercise tolerance. PHYSACTO® (NCT02085161) tested the effects of long-acting bronchodilators alone or combined with exercise training (ExT) on exercise endurance time (EET) in patients with COPD. All patients took part in a standardised physical activity self-management behaviour-modification (BM) programme.
Methods A 12-week, randomised, partially double-blind, placebo-controlled, parallel-group trial at 34 sites in Australia, New Zealand, USA, Canada and Europe. Interventions (all with 12-week BM) were: BM + placebo; BM + tiotropium (T) 5 µg; BM + T + olodaterol (T/O) 5/5 µg; BM + T/O 5/5 µg with 8 weeks’ ExT (T/O 5/5 µg + ExT). EET (log transformed) during an endurance shuttle-walk test (ESWT) to symptom limitation was assessed after 8 weeks (primary end point) and 12 weeks.
Results 303 patients (200 men) were randomised and treated (full analysis set n=274). Mean post-bronchodilator forced expiratory volume in 1 second was 1.59 L (57% predicted). EET was significantly increased in patients receiving BM + T/O 5/5 µg compared to placebo and was increased to a greater extent in patients receiving BM + T/O 5/5 µg + ExT compared to placebo at 8 weeks. EET was not significantly increased in patients receiving BM + T 5 µg compared to placebo (Table). Similar increases in EET were demonstrated at 12 weeks (Table). 13 patients reached test termination criteria (20 minutes) without symptom limitation (placebo, n=0; T, n=3; T/O, n=2; T/O + ExT, n=8) at 8 weeks. No safety concerns were identified.
Conclusions When added to BM, the bronchodilator combination T/O 5/5 µg, used alone and combined with ExT, improved EET during ESWT compared to placebo in moderate to severe COPD.
Funding Boehringer Ingelheim.
Please refer to page A270 for declarations of interest in relation to abstract S34.