Journal
INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Volume 12, Issue -, Pages 2545-2558Publisher
DOVE MEDICAL PRESS LTD
DOI: 10.2147/COPD.S143488
Keywords
COPD; hyperinflation; aclidinium; formoterol; exercise capacity; physical activity
Categories
Funding
- AstraZeneca
- Menarini Group through Berlin-Chemie
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The Phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study (NCT02424344) evaluated the effect of aclidinium/formoterol (AB/FF) 400/12 mu g twice daily on lung hyperinflation, exercise capacity, and physical activity in patients with moderate-to-severe COPD. Patients received AB/FF (n=134) or placebo (n=133) (1: 1) via the Genuair (TM)/Pressair (R) dry powder inhaler for 8 weeks. From Weeks 5 to 8, all patients participated in behavioral intervention (BI; daily messages providing step goals). The primary end point was trough functional residual capacity (FRC) at Week 4. Exercise endurance time and physical activity were assessed at Week 4 (pharmacotherapy only) and at Week 8 (8 weeks of pharmacotherapy plus 4 weeks of BI). Other end points included post-dose FRC, residual volume, and inspiratory capacity (IC) at rest and during exercise. After 4 weeks, trough FRC improved with AB/FF versus placebo but did not reach significance (125 mL; P=0.0690). However, post-dose FRC, residual volume, and IC at rest improved significantly with AB/FF at Week 4 versus placebo (all P < 0.0001). 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). 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 observed with placebo. AB/FF 400/12 mu g demonstrated improvements in lung hyperinflation, exercise capacity, and physical activity versus placebo that were maintained following the addition of BI. A 4-week period of BI might be too short to augment the improvements of physical activity observed with AB/FF.
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