Evaluation of the efficacy of Tiotropium/Olodaterol by a dynamic flat-panel detector system
- Conditions
- Chronic Obstructive Pulmonary DiseaseDynamic-Ventilatory Digital Radiography,COPD,tiotropium/olodaterolD029424
- Registration Number
- JPRN-jRCTs032210543
- Lead Sponsor
- Ikari Jun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
1) Patients diagnosed with chronic pulmonary disease (COPD) who have been or are going to be treated with medical therapy
2) Patients aged 40 to 85 at the time of obtaining consent
3) Both male and female are eligible.
4) Patients who have smoked more than 10 pack-years
5) Patients with airway obstruction with a post-bronchodilator FEV1 <80% of predicted normal , FEV1 >30%of predicted normal and FEV1/FVC <70%
6) Patients who can perform forced breathing, rest breathing and breath holding in standing position
7) Written informed consent
1) Patients with a history of asthma or currently diagnosed with asthma
2) Patients who cannot perform pulmonary function testing properly (including the history of pulmonary resection)
3) Patients with impaired mobility, including walking ability, by limb dysfunction or with bone fracture
4) Patients who have experienced exacerbation of COPD within 1 month
5) Patients with tachycardia more than 100 beats per min or life-threatening arrhythmia
6) Patients who have experienced acute myocardial infarction or have history of hospital admission for heart failure, within 1 year
7) Patients who have history of cancer (excluding basal cell carcinoma, squamous epithelial skin cancer, Endoscopic mucosal resection for gastrointestinal tumors). (However, this excludes cases where it is expected that there will be no recurrence of cancer requiring treatment during the period of participation in this study, with PS 0 at the time of registration of this study at the discretion of a specialist, and there is no problem with walking.)
8) Patients who do not understand the purpose and method of research
9) Patients with obvious dementia
10) Patients who are being treated for depression or neurosis (scores are not used, at the discretion of the doctor)
11) Patients with angle-closure glaucoma, dysuria due to benign prostatic hyperplasia, patients with a history of hypersensitivity to atropine and its related substances or components of this drug
12) Pregnant or lactating women, women who can become pregnant but cannot use contraception
13) Patients who are judged to have difficulty with temporary suspension of medication when taking LAMA or LABA
14) Patients who are judged by the principal investigator or subinvestigator to be inappropriate as the target person
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of change in surface area
- Secondary Outcome Measures
Name Time Method Excursion of diaphragm<br>Motion speed of diaphragm<br>Tracheal diameter change<br>Tracheal narrowing rate<br>Maximum Pixel Change Rate<br>Pulmonary function testing<br>BDI/TDI score<br>CAT score<br>Frequency of adverse events<br>Equipment malfunction<br>ventilation, perfusion, ventilation-perfusion ratio<br>Chest CT parameters