Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598307
Posterbegehung – Sektion Klinische Pneumologie
COPD I – Andreas Rembert Koczulla/Marburg, Henrik Watz/Großhansdorf
Georg Thieme Verlag KG Stuttgart · New York

Effect of 8 and 12 weeks' once-daily tiotropium and olodaterol, alone and combined with exercise training, on exercise endurance during walking in patients with COPD

T Troosters
1  Ku Leuven, Department of Rehabilitation Sciences and University Hospital Leuven, Pulmonary Rehabilitation and Respiratory Division
,
J Bourbeau
2  Mcgill University Health Centre
,
F Maltais
3  Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Université Laval
,
N Leidy
4  Evidera, Bethesda
,
D Erzen
5  Boehringer Ingelheim Pharma GmbH & Co. KG
,
D De Sousa
6  Boehringer Ingelheim (Canada) Ltd
,
L Korducki
7  Boehringer Ingelheim Pharmaceuticals Inc.
,
KL Lavoie
8  Montreal Behavioural Medicine Centre, Research Centre, Hopital du Sacré-Coeur de Montreal; Department of Psychology, University of Quebec at Montreal (Uqam)
,
W Janssens
9  Respiratory Division, University Hospital Gasthuisberg
,
A Hamilton
6  Boehringer Ingelheim (Canada) Ltd
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

 

Introduction:

Physical deconditioning is common in patients with COPD, limiting exercise tolerance.

Aim:

PHYSACTO® (NCT02085161) tested the effects of bronchodilators alone or with exercise training (ExT), combined with a standardised physical activity self-management behaviour-modification (BM) programme, on exercise endurance time (EET) in patients with COPD.

Methods:

A 12-week (wk) randomised, partially double-blind, placebo (P)-controlled, parallel-group trial at 34 sites in Australia, New Zealand, USA, Canada and Europe. Interventions (all with 12-wk BM): P; tiotropium (T) 5 µg; T + olodaterol (T+O) 5/5 µg; T+O 5/5 µg with 8 wks' ExT (T+O 5/5 µg + ExT). EET (log transformed) during an endurance shuttle-walk test (ESWT) to symptom limitation was assessed after 8 wks (primary end point) and 12 wks.

Results:

303 patients (200 men) were randomised and treated (full analysis set n = 274). Mean post-bronchodilator FEV1 was 1.59 L (56.7% predicted). EET significantly increased with T+O 5/5 µg and T+O 5/5 µg + ExT versus P at 8 wks (Fig); 13 patients reached test termination criteria (20 mins) without symptom limitation (P, n = 0; T, n = 3; T+O, n = 2; T+O + ExT, n = 8) at 8 wks. No safety concerns were identified.

Conclusions:

T+O 5/5 µg, alone and combined with ExT, improved EET during ESWT compared to P in moderate to severe COPD.

Funding:

Boehringer Ingelheim

Zoom Image
Fig. 1: Geometric mean results reported as primary analysis based on log10-transformed data. ExT was stopped after 8 weeks but all groups continued study medication up to 12 weeks
Geometric mean baseline endurance time: 242.73 s (Week 8); 241.96 s (Week 12)
Patient numbers at Week 8: P + BM = 65; T 5 µg + BM = 67; T+O 5/5 µg + BM = 72: T+O 5/5 µg + ExT + BM = 70
Patient numbers at Week 12: P + BM = 62; T 5 µg + BM = 64; T+O 5/5 µg + BM = 71; T+O 5/5 µg + ExT + BM = 66
*p < 0.05; **p < 0.01; ***p < 0.001 for % improvement from P (p values at Week 12 were nominal)
SE, standard error

Content already presented at ERS congress 2016