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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027190

Enrollment

Registered

2017-04-29

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD (Chronic obstructive pulmonary disease)

Interventions

Interventions: combination treatment with tiotropium and olodaterol for 12 weeks Control: treatment with tiotropium for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with COPD (FEV1/FVC<70%) and %FEV1<80% 2.Current or past smokers 3.Maintenance treatment naive patients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Peak FEV1 (post 1 hour inhalation with the combination of tiotropium and olodaterol or tiotropium)	—

Secondary

Measure	Time frame
1.Physical activity (triaxial accelerometer) on before and after 12 weeks treatment 2.Quality of life(CAT) on before and after 12 weeks treatment 3.Inspiratory capacity on before and after 12 weeks treatment 4.TDI scale (dyspnea) on before and after 12 weeks treatment 5.6MWD and modified Borg scale scores on before and after 12 weeks treatment	—

Countries

Japan

Contacts

Public ContactKoichiro Takahashi

Saga University Faculty of medicine, department of internal medicine, Division of respiratory medicine,

takahak@cc.saga-u.ac.jp0952-34-2369

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026