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

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.

Journal

Journal ID (nlm-ta): Int J Chron Obstruct Pulmon Dis

Journal ID (iso-abbrev): Int J Chron Obstruct Pulmon Dis

Journal ID (publisher-id): International Journal of COPD

Title: International Journal of Chronic Obstructive Pulmonary Disease

Publisher: Dove Medical Press

ISSN (Print): 1176-9106

ISSN (Electronic): 1178-2005

Publication date Collection: 2017

Publication date (Electronic): 24 August 2017

Volume: 12

Pages: 2545-2558

Affiliations

[1 ]Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany

[2 ]Department of Rehabilitation Sciences, Pulmonary Rehabilitation and Respiratory Division, University Hospital Leuven, KU Leuven, Leuven, Belgium

[3 ]insaf Respiratory Research Institute GmbH, Wiesbaden, Germany

[4 ]Barcelona Institute of Global Health (ISGlobal), Barcelona, Spain

[5 ]Universitat Pompeu Fabra (UPF), Barcelona, Spain

[6 ]CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain

[7 ]Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy

[8 ]AstraZeneca PLC, Barcelona, Spain

[9 ]A. Menarini Farmaceutica Internazionale S.R.L., Firenze, Italy

[10 ]Laboratorios Menarini, S.A., Badalona, Spain

Author notes

Correspondence: Henrik Watz, Pulmonary Research Institute at LungenClinic Grosshansdorf, Wöhrendamm 80, 22927 Grosshansdorf, Germany, Tel [phone], Fax [phone], Email h.watz@ 123456pulmoresearch.de

Article

Publisher ID: copd-12-2545

DOI: 10.2147/COPD.S143488

PMC ID: 5574699

Copyright statement: © 2017 Watz et al. This work is published and licensed by Dove Medical Press Limited

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Categories

Subject: Original Research