Abstract
Rationale
The Daily PROactive Physical Activity in COPD (D-PPAC) instrument combines 7 questions and 2 activity-monitoring variables to assess physical activity in patients with COPD. However, a limited number of studies have so far used it as an outcome measure. The D-PPAC instrument was used in ACTIVATE (a Phase IV, randomized, placebo-controlled study; NCT02424344) to assess the effect of aclidinium/formoterol (AB/FF) on physical activity with and without behavioural intervention (BI). The primary outcome (lung hyperinflation) has been reported previously.
Methods: Patients with moderate/severe COPD received AB/FF 400/12 μg or placebo (PBO) BID (1:1) for 8 weeks. In Weeks 4–8, all patients received telecoaching BI. D-PPAC Total, Difficulty and Amount scores (all ranging from 0 to 100) were evaluated at Weeks 4 and 8.
Results: 267 patients were randomized. At Week 4, patients receiving AB/FF showed a significant increase from baseline in D-PPAC scores vs PBO, and the percentage of patients with clinically meaningful improvements in Total and Amount scores was significantly higher with AB/FF vs PBO (Table). At Week 8, the improvements in patients receiving AB/FF + BI were less marked than at Week 4 (AB/FF only); Total and Amount scores were modestly improved with PBO + BI (Table).
Conclusion: AB/FF 400/12 µg significantly improved D-PPAC scores vs PBO at Week 4. BI did not augment these improvements.
- Copyright ©the authors 2017
