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2017-08-24

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cc by-nc (c) Watz et al., 2017
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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http://dx.doi.org/10.2147/COPD.S143488

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.

Subject

Malalties pulmonars obstructives cròniques, Condició física

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Chronic obstructive pulmonary diseases, Physical fitness

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Articles publicats en revistes (ISGlobal)

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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: 9 of August of 2026]. Available at: https://hdl.handle.net/2445/116223

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