Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Participants take Spiolto respimat(tiotropim bromide hydrate/olodaterol hydrochloride) or Spiriva respimat(tiotropium bromide hydrate) for 12 weeks.
Sponsors
Takahashi Koichiro
Aragane Naoko
Nippon Boehringer Ingelheim co ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are over 40 years old and under 85 years old 2) male and female 3) COPD (FEV 1 / FVC <70%) diagnosis in respiratory function test after bronchodilator inhalation, and those with% FEV 1 <80% 4) Current smoker (10 pack-years or more) or smoker (smoking history of 10 pack-years or more, and quit smoking for over 1 year) 5) In the past 12 months, those who have not received periodic treatment for COPD Treatment for COPD refers to treatment with LABA, LAMA, ICS. ICS, LABA, tulobuterol patches should not be used for the past month. 6) Patients who obtained consent in writing about participation in this research
Exclusion criteria
Exclusion criteria: 1) Patients who has a history of asthma. 2) Those who can not properly perform pulmonary function test (including lung lobectomy) 3) Patients whose mobility such as walking is impaired by limb function impairment, those who are fractured. 4) Patients who is within 1 month from acute exacerbation of COPD. 5) Patients with paroxysmal tachycardia (over 100 / min) or life-threatening arrhythmia. 6) Patients who have a history of acute myocardial infarction in the past year, those who have been hospitalized for heart failure in the past year 7) Patients who have a history of malignant tumor within 5 years. (excluding skin basal cell carcinoma and squamous epithelial skin carcinoma, excluding case where only endoscopic mucosal resection was performed with gastrointestinal malignant tumor. Excluding patients who are PS 0, without any problems on walking, excluding cases where it is expected that there will be no recurrence of cancer that needs treatment during this study participation period at the time of this research registration) 8) Patients who can not understand the purpose and method of research 9) Patients with obvious dementia 10) Patients under treatment for depression and neurosis. 11) Patients who have dysuria due to closed angle glaucoma, prostate hypertrophy, those who have a history of hypersensitivity to atropine and its analogous substances or components of this drug 12) Patients judged by the attending physician to be inappropriate as the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced expiratory volume 1 second at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical activity (measured by accelerometer) Quality of life (COPD assessment test) Inspiratory capacity Symptoms (TDI score) Six minuites walk distance and Borg's scale | — |
Contacts
Public ContactKoichiro Takahashi
Faculty of Medicine, Saga University
Outcome results
None listed