ACTIVATE: effect of aclidinium/formoterol on physical activity in patients with COPD

Rationale: Patients with COPD are characterized by a sedentary lifestyle and reduced physical activity (PA). Lung hyperinflation contributes to the exertional dyspnoea that limits PA. ACTIVATE (NCT02424344) assessed the effects of aclidinium/formoterol (AB/FF) on PA with/without behavioural intervention (BI) as a secondary objective. The primary objective, the effect of AB/FF on lung hyperinflation, has been reported previously. Methods: In this Phase IV, randomized, placebo-controlled study, patients with moderate/severe COPD received AB/FF 400/12 μg or placebo BID (1:1) for 8 weeks. In Weeks 4–8, all patients received telecoaching BI. PA (steps/day; activity monitor) was evaluated at Weeks 4 and 8. Results: 267 patients were randomized. At Week 4, a clinically meaningful increase from baseline of 731 steps/day was seen with AB/FF vs placebo (p 600 and >1000 steps/day, and the percentage of inactive patients was lower, with AB/FF vs placebo (all p Conclusion: AB/FF 400/12 µg significantly improved PA vs placebo at Week 4. Effects were sustained to Week 8. BI did not augment these improvements.