JPRN-jRCTs071180021已完成4 期
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 - SCOPE study (Saga naive COPD Physical activity Evaluation study)
Takahashi Koichiro0 个研究点目标入组 80 人开始时间: 2019年2月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
These results suggested that tiotropium / olodaterol treatment for untreated COPD may lead to improvement in physical activity as well as improvement in pulmonary functions.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 <= 84age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
4 期
Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)COPDNCT00996697Brian J Lipworth23
招募中
不适用
Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT05295355Guangzhou Institute of Respiratory Disease72
已完成
4 期
Cardiovascular Function in COPD PatientsPulmonary Disease, Chronic ObstructiveNCT03055988Boehringer Ingelheim76
已完成
不适用
Efficacy of Tiotropium in Patients after Pulmonary ResectionsJPRN-UMIN000001523Toneyama National Hospital20
已完成
不适用
Impact of Tiotropium Add-on Therapy in Patients With AsthmaAsthmaNCT03964220Boehringer Ingelheim7,857