The effect of the combination treatment with tiotropium and olodaterol compared to tiotropium on symptoms, respiratory functions and physical activity in maintenance naive Japanese patient with COPD

Not Applicable

• Conditions: COPD (Chronic obstructive pulmonary disease)

• Registration Number: JPRN-UMIN000027190
• Lead Sponsor: Saga University

Brief Summary

Tiotropium/olodaterol treatment reduced the duration of physical activity with 1.0-1.5METs(regression coefficient,-43.6 [95%CI -84.1, -3.1], p=0.04)in a multiple regression model adjusted for cofounding factors such as age, FEV1, total CAT scores, 6MWD, and TDI.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-29
• Study Completion: 2019-05-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who have bronchial asthma 2.Patients who are able to examine a pulmonary function test 3.Patients who are disturbed in walk ability or have a bone fracture 4.Patients who have experiences of exacerbation of COPD within 1 month 5.Patients with paroxysmal tachycardia (over 100 / min) and life threatening arrhythmia 6.Patients who have experiences of acute myocardial infarction or heart failure within 1 year 7.Patients who have experiences of malignant tumor ( excluding basal cell carcinoma or epithelial cancer of skin) within 5 years 8.Patients who do not understand purpose or method of the study 9.Patients with dementia 10.Patients who are being treated for depression and neurosis 11.Patients who have angle-closure glaucoma, benign prostatic hyperplasia with dysuria and hypersensitivity to atropine and its analogous substances or components of the drug 12.Patients who are judged not to be suitable as subjects

Study & Design

• Study Type: Interventional
• Study Design: Not specified