ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD

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• dc.contributor.author Watz, Henrik
• dc.contributor.author Troosters, Thierry
• dc.contributor.author Beeh, Kai M.
• dc.contributor.author García Aymerich, Judith
• dc.contributor.author Paggiaro, Pierluigi
• dc.contributor.author Molins, Eduard
• dc.contributor.author Notari, Massimo
• dc.contributor.author Zapata, Antonio
• dc.contributor.author Jarreta, Diana
• dc.contributor.author Garcia Gil, Esther
• dc.date.accessioned 2025-02-03T07:51:32Z
• dc.date.available 2025-02-03T07:51:32Z
• dc.date.issued 2017
• dc.description.abstract The Phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study (NCT02424344) evaluated the effect 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. Patients received AB/FF (n=134) or placebo (n=133) (1:1) via the Genuair™/Pressair® 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 µg 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.en
• dc.format.mimetype application/pdf
• dc.identifier.citation Watz H, Troosters T, Beeh KM, Garcia J, Paggiaro P, Molins E, et al. ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2017 Aug;12:2545-58. DOI: 10.2147/COPD.S143488
• dc.identifier.doi http://dx.doi.org/10.2147/COPD.S143488
• dc.identifier.issn 1176-9106
• dc.identifier.uri http://hdl.handle.net/10230/69447
• dc.language.iso eng
• dc.publisher Taylor & Francis
• dc.relation.ispartof International Journal of Chronic Obstructive Pulmonary Disease. 2017 Aug;12:2545-58
• dc.rights © 2017 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/3.0/
• dc.subject.keyword COPDen
• dc.subject.keyword Hyperinflationen
• dc.subject.keyword Aclidiniumen
• dc.subject.keyword Formoterolen
• dc.subject.keyword Exercise capacityen
• dc.subject.keyword Physical activityen
• dc.title ACTIVATE: the effect of aclidinium/formoterol on hyperinflation, exercise capacity, and physical activity in patients with COPDen
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion