Differential outcomes following 4 weeks of aclidinium/formoterol in patients with COPD: a reanalysis of the ACTIVATE study

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  • dc.contributor.author Koopman, Maud
  • dc.contributor.author Franssen, Frits M. E.
  • dc.contributor.author Gaffron, Swetlana
  • dc.contributor.author Watz, Henrik
  • dc.contributor.author Troosters, Thierry
  • dc.contributor.author García Aymerich, Judith
  • dc.contributor.author Paggiaro, Pierluigi
  • dc.contributor.author Molins, Eduard
  • dc.contributor.author Moya, Miguel
  • dc.contributor.author van Burk, Lindy
  • dc.contributor.author Maier, Dieter
  • dc.contributor.author Garcia Gil, Esther
  • dc.contributor.author Wouters, Emiel
  • dc.contributor.author Vanfleteren, Lowie E. G. W.
  • dc.contributor.author Spruit, Martijn A.
  • dc.date.accessioned 2022-12-13T09:21:41Z
  • dc.date.available 2022-12-13T09:21:41Z
  • dc.date.issued 2022
  • dc.description.abstract Rationale: It is difficult to predict the effects of long-acting bronchodilators (LABD) on lung function, exercise capacity and physical activity in patients with chronic obstructive pulmonary disease (COPD). Therefore, the multidimensional response to LABD was profiled in COPD patients participating in the ACTIVATE study and randomized to LABD. Methods: In the ACTIVATE study, patients were randomized to aclidinium bromide/formoterol fumarate (AB/FF) or placebo for four weeks. The primary outcomes included (1) lung function as measured by functional residual capacity (FRC), residual volume (RV), and spirometric outcomes; (2) exercise performance as measured by a constant work rate cycle ergometry test (CWRT); and (3) physical activity (PA) using an activity monitor. Self-organizing maps (SOMs) were used to create an ordered representation of the patients who were randomly assigned to four weeks of AB/FF and cluster them into different outcome groups. Results: A total of 250 patients were randomized to AB/FF (n = 126) or placebo (n = 124). Patients in the AB/FF group (39.6% women) had moderate-to-severe COPD, static hyperinflation (FRC: 151.4 (27.7)% predicted) and preserved exercise capacity. Six clusters with differential outcomes were identified. Patients in clusters 1 and 2 had significant improvements in lung function compared to the remaining AB/FF-treated patients. Patients in clusters 1 and 3 had significant improvements in CWRT time, and patients in clusters 2, 3 and 6 had significant improvements in PA compared to the remaining AB/FF-treated patients. Conclusion: Individual responses to 4 weeks of AB/FF-treatment in COPD are differential and the degree of change differs across domains of lung function, exercise capacity and PA. These results indicate that clinical response to LABD therapy is difficult to predict and is non-linear, and show doctors that it is important to look at multiple outcomes simultaneously when evaluating the clinical response to LABD therapy. Clinical trial registration: The original ACTIVATE study was registered on ClinicalTrials.gov, registration number NCT02424344.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Koopman M, Franssen FME, Gaffron S, Watz H, Troosters T, Garcia-Aymerich J, Paggiaro P, Molins E, Moya M, van Burk L, Maier D, Garcia Gil E, Wouters EFM, Vanfleteren LEGW, Spruit MA. Differential outcomes following 4 weeks of aclidinium/formoterol in patients with COPD: a reanalysis of the ACTIVATE study. Int J Chron Obstruct Pulmon Dis. 2022 Mar 8;17:517-33. DOI: 10.2147/COPD.S308600
  • dc.identifier.doi http://dx.doi.org/10.2147/COPD.S308600
  • dc.identifier.issn 1176-9106
  • dc.identifier.uri http://hdl.handle.net/10230/55122
  • dc.language.iso eng
  • dc.publisher DOVE Medical Press
  • dc.relation.ispartof Int J Chron Obstruct Pulmon Dis. 2022 Mar 8;17:517-33
  • dc.rights © 2022 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 https://creativecommons.org/licenses/by-nc/3.0/
  • dc.subject.keyword COPD
  • dc.subject.keyword Hyperinflation
  • dc.subject.keyword Physical activity
  • dc.title Differential outcomes following 4 weeks of aclidinium/formoterol in patients with COPD: a reanalysis of the ACTIVATE study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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