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Adv Ther. 2017 Jul;34(7):1622-1635. doi: 10.1007/s12325-017-0554-3. Epub 2017 May 23.

Study Design of VESUTO®: Efficacy of Tiotropium/Olodaterol on Lung Hyperinflation, Exercise Capacity, and Physical Activity in Japanese Patients with Chronic Obstructive Pulmonary Disease.

Author information

1
Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan. ichinose@rm.med.tohoku.ac.jp.
2
Department of Respiratory Medicine, National Hospital Organization Wakayama Hospital, 1138 Wada, Mihama-cho, Hidaka-gun, Wakayama, 644-0044, Japan.
3
Division of Pulmonary Medicine, Infectious Disease, and Oncology, Department of Internal Medicine, Nippon Medical School, 4-7-15 Kudan-minami, Chiyoda-ku, Tokyo, 102-0074, Japan.
4
Clinical Research Unit of Respiratory Pathophysiology, Juntendo University Graduate School of Health Care and Nursing, 2-5-1, Takasu, Urayasu City, Chiba, 279-0023, Japan.
5
Medical Division, Nippon Boehringer Ingelheim Co., Ltd, 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.
6
Clinical Information Division Data Science Center, Statistics Analysis Department, 1 EPS Corporation, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, 162-0814, Japan.
7
Medicine TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 , Ingelheim am Rhein, Germany.
8
Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.

Abstract

INTRODUCTION:

The superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD.

METHODS:

A protocol is developed for the VESUTO® study that investigates the efficacy of tiotropium/olodaterol fixed-dose combination (FDC) compared with tiotropium alone on inspiratory capacity (IC, volume from functional residual capacity to total lung capacity), exercise capacity, and daily physical activity in Japanese patients with COPD.

RESULTS:

A total of 180 Japanese patients with COPD, aged ≥40 years will be enrolled into the double-blind, multicenter, active-controlled, crossover study (NCT02629965) and will be randomized to receive either tiotropium/olodaterol FDC or tiotropium for 6 weeks each [two puffs via RESPIMAT® (Boehringer Ingelheim, Ingelheim, Germany) inhaler in the morning]. The primary endpoint is IC at rest measured at 60 min post-dose after 6 weeks treatment. The secondary endpoints include the 6-min walk distance (6MWD) at 90 min post-dose and physical activity measured by the activity monitor in the last 2 weeks of the 6-week treatment periods. Lung function tests will also be assessed after 6 weeks treatment. A mixed-effects model repeated measures approach will be used for the primary and secondary endpoints.

CONCLUSION:

The VESUTO® study is the first randomized interventional study to investigate exercise capacity (6MWD) and physical activity measured by a 3-axis accelerometer in Japanese patients with COPD. The study could provide additional evidence of long-acting muscarinic antagonist (LAMA) + long-acting β2-agonist (LABA) combination therapy on patients' physical activities as well as lung function.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT02629965 (registered on December 1, 2015).

FUNDING:

The VESUTO study was funded by Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.

KEYWORDS:

Exercise tolerance capacity; Inspiratory capacity; Olodaterol; Physical activity; Respiratory; Tiotropium

PMID:
28537001
PMCID:
PMC5504218
DOI:
10.1007/s12325-017-0554-3
[Indexed for MEDLINE]
Free PMC Article

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