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International Journal of Chronic Obstructive Pulmonary Disease Volume 12, 2017 - Issue
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Original Research

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

Henrik Watz1 Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, GermanyCorrespondence[email protected]
,
Thierry Troosters2 Department of Rehabilitation Sciences, Pulmonary Rehabilitation and Respiratory Division, University Hospital Leuven, KU Leuven, Leuven, Belgium
,
Kai M Beeh3 insaf Respiratory Research Institute GmbH, Wiesbaden, Germany
,
Judith Garcia-Aymerich4 Barcelona Institute of Global Health (ISGlobal), Barcelona, Spain;5 Universitat Pompeu Fabra (UPF), Barcelona, Spain;6 CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
,
Pierluigi Paggiaro7 Department of Surgery, Medicine, Molecular Biology and Critical Care, University of Pisa, Pisa, Italy
,
Eduard Molins8 AstraZeneca PLC, Barcelona, Spain
,
Massimo Notari9 A. Menarini Farmaceutica Internazionale S.R.L., Firenze, Italy
,
Antonio Zapata10 Laboratorios Menarini, S.A., Badalona, Spain
,
Diana Jarreta8 AstraZeneca PLC, Barcelona, Spain
&
Esther Garcia Gil8 AstraZeneca PLC, Barcelona, Spain
 show all
Pages 2545-2558 | Published online: 24 Aug 2017

Figures & data

Figure 1 Study design.

Abbreviations: BI, behavioral intervention; b.i.d., twice daily; V, visit; W, week.
Figure 1 Study design.

Table 1 Baseline demographics and clinical characteristics (ITT population)

Figure 2 Patient flow.

Abbreviations: AB, aclidinium bromide; AE, adverse event; FF, formoterol fumarate.
Figure 2 Patient flow.

Figure 3 Change from baseline in trough FRC at Week 4 (ITT population).

Note: Data are LSMs (95% CI).
Abbreviations: AB, aclidinium bromide; CI, confidence interval; FF, formoterol fumarate; FRC, functional residual capacity; ITT, intent-to-treat; LSM, least squares mean.
Figure 3 Change from baseline in trough FRC at Week 4 (ITT population).

Table 2 Lung function at Week 4 (ITT population)

Figure 4 Change from baseline in (A) EET at Week 4 (after pharmacotherapy only) and at Week 8 (after pharmacotherapy and BI), and (B) IC during constant work rate cycle ergometry at Week 8 (ITT population).

Notes: aFor each individual patient, isotime was defined as the minimum EET among the constant work rate exercise tests at 75% Wmax performed on Visits 2, 3, 4, and 5. Data are LSMs (95% CI).
Abbreviations: AB, aclidinium bromide; BI, behavioral intervention; CI, confidence interval; EET, exercise endurance time; FF, formoterol fumarate; IC, inspiratory capacity; ITT, intent-to-treat; LSM, least squares mean; Wmax, peak work rate.
Figure 4 Change from baseline in (A) EET at Week 4 (after pharmacotherapy only) and at Week 8 (after pharmacotherapy and BI), and (B) IC during constant work rate cycle ergometry at Week 8 (ITT population).

Figure 5 (A) Percentage of inactive patients (<6,000 steps per day) over 8 weeks (ITT population) and (B) absolute number of steps per day over 8 weeks (ITT population).

Note: Steps per day data are LSM ± SE.
Abbreviations: AB, aclidinium bromide; BI, behavioral intervention; CI, confidence interval; FF, formoterol fumarate; ITT, intent-to-treat; LSM, least squares mean; OR, odds ratio; SE, standard error.
Figure 5 (A) Percentage of inactive patients (<6,000 steps per day) over 8 weeks (ITT population) and (B) absolute number of steps per day over 8 weeks (ITT population).

Figure 6 Change from baseline in D-PPAC total score and amount and difficulty domains at Weeks 4 and 8 (ITT population).

Note: Data are LSMs (95% CI).
Abbreviations: AB, aclidinium bromide; BI, behavioral intervention; CI, confidence interval; D-PPAC, Daily PROactive Physical in COPD; FF, formoterol fumarate; ITT, intent-to-treat; LSM, least squares mean.
Figure 6 Change from baseline in D-PPAC total score and amount and difficulty domains at Weeks 4 and 8 (ITT population).

Figure S1 Change from baseline in daily duration of at least moderate activitiesa at Week 4 (ITT population).

Notes: Data are LSMs (95% CI). aModerate activities are those with an intensity ≥3.0 METs.

Abbreviations: AB, aclidinium bromide; CI, confidence interval; FF, formoterol fumarate; ITT, intent-to-treat; LSM, least squares mean; MET, metabolic equivalents.

Figure S1 Change from baseline in daily duration of at least moderate activitiesa at Week 4 (ITT population).Notes: Data are LSMs (95% CI). aModerate activities are those with an intensity ≥3.0 METs.Abbreviations: AB, aclidinium bromide; CI, confidence interval; FF, formoterol fumarate; ITT, intent-to-treat; LSM, least squares mean; MET, metabolic equivalents.

Figure S2 Change from baseline in activity-related energy expenditure at Week 4 (ITT population).

Note: Data are LSMs (95% CI).

Abbreviations: AB, aclidinium bromide; CI, confidence interval; FF, formoterol fumarate; ITT, intent-to-treat; LSM, least squares mean.

Figure S2 Change from baseline in activity-related energy expenditure at Week 4 (ITT population).Note: Data are LSMs (95% CI).Abbreviations: AB, aclidinium bromide; CI, confidence interval; FF, formoterol fumarate; ITT, intent-to-treat; LSM, least squares mean.

Table S1 IECs/IRBs consulted

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