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Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/116223
ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD
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Abstract
The Phase IV, 8-week, randomized, double-blind,
placebo-controlled ACTIVATE study (NCT02424344) evaluated the
effect of aclidinium/formoterol (AB/FF) 400/12 mug 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/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 mug
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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WATZ, Henrik, et al. ACTIVATE: the effect of aclidinium/formoterol on hyperinflation,
exercise capacity, and physical activity in patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease. 2017. Vol. 12, pags. 2545-2558. ISSN 1176-9106. [consulted: 13 of June of 2026]. Available at: https://hdl.handle.net/2445/116223