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

JRCT ID: jRCTs071180021

Registered date:21/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease
• Date of first enrollment: 07/07/2017
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Participants take Spiolto respimat(tiotropim bromide hydrate/olodaterol hydrochloride) or Spiriva respimat(tiotropium bromide hydrate) for 12 weeks.

Outcome(s)

• Primary Outcome: Forced expiratory volume 1 second at 12 weeks

Secondary Outcome

Physical activity (measured by accelerometer)
Quality of life (COPD assessment test)
Inspiratory capacity
Symptoms (TDI score)
Six minuites walk distance and Borg's scale

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 84age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takahashi Koichiro
• Secondary Sponsor: Aragane Naoko,Nippon Boehringer Ingelheim co ltd.