Watz H, et al. – This analysis focused on the impact of aclidinium/formoterol (AB/FF) 400/12 µg twice daily on lung hyperinflation, exercise capacity, and physical activity in patients with moderate–to–severe COPD. It was concluded that AB/FF 400/12 µg showed improvements in lung hyperinflation, exercise capacity, and physical activity versus placebo that were maintained following the addition of behavioral intervention (BI). The findings suggested that a 4–week period of BI might be too short to augment the improvements of physical activity observed with AB/FF.

Methods

• It was a phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study. 
• For this purpose, patients received AB/FF (n=134) or placebo (n=133) (1:1) via the Genuair/Pressair dry powder inhaler for eight weeks.
• From Weeks 5 to 8, all patients partook in behavioral intervention (BI; daily messages providing step goals).
• At Week 4, trough functional residual capacity (FRC) was the primary end point.
• Exercise endurance time and physical activity were evaluated at Week 4 (pharmacotherapy only) and at Week 8 (8 weeks of pharmacotherapy plus 4 weeks of BI).
• Other end points involved post-dose FRC, residual volume, and inspiratory capacity (IC) at rest and during exercise.

Results

• The results of this study showed that trough FRC improved with AB/FF versus placebo but did not reach significance (125 mL; P=0.0690) after 4 weeks.
• It was noted that post-dose FRC, residual volume, and IC at rest improved significantly with AB/FF at Week 4 versus placebo (all P<0.0001).
• Findings revealed that AB/FF significantly improved exercise endurance time and IC at isotime versus placebo at Week 4 (P<0.01 and P<0.0001, respectively) and Week 8 (P<0.05 and P<0.0001, respectively).
• In addition, AB/FF achieved higher step counts (P<0.01) with fewer inactive patients (P<0.0001) at Week 4 versus placebo.  
• Following BI, AB/FF maintained improvements in physical activity at Week 8 and nonsignificant improvements were seen with placebo.