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

Autor: Jun Ueki, Masakazu Ichinose, Takashi Motegi, Lars Grönke, Tatsuhiko Anzai, Ayako Takizawa, Kazuto Hirata, Tetsuo Seki, Yoshiaki Minakata
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Male
Lung hyperinflation
chemistry.chemical_compound
Pulmonary Disease
Chronic Obstructive
0302 clinical medicine
Quality of life
Japan
Pharmacology (medical)
030212 general & internal medicine
Respiratory system
Original Research
Aged
80 and over
COPD
Cross-Over Studies
Exercise Tolerance
Olodaterol
General Medicine
Middle Aged
Bronchodilator Agents
Respiratory Function Tests
Inspiratory capacity
Respiratory
Female
Adult
medicine.medical_specialty
Physical activity
Pulmonary disease
03 medical and health sciences
Double-Blind Method
Internal medicine
Administration
Inhalation
medicine
Humans
Tiotropium Bromide
Intensive care medicine
Aged
Dose-Response Relationship
Drug
business.industry
Tiotropium
Exercise tolerance capacity
medicine.disease
Rheumatology
respiratory tract diseases
Benzoxazines
030228 respiratory system
chemistry
Quality of Life
business
Zdroj: Advances in Therapy
ISSN: 1865-8652
0741-238X
Popis: 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. Electronic supplementary material The online version of this article (doi:10.1007/s12325-017-0554-3) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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