Evaluation of the efficacy of Tiotropium/Olodaterol by a dynamic flat-panel detector system

JRCT ID: jRCTs032210543

Registered date:11/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease
• Date of first enrollment: 26/08/2022
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Conducting X-ray dynamic image inspection by a dynamic flat-panel detector system, chest CT, administration of tiotropium/olodaterol

Outcome(s)

• Primary Outcome: Rate of change in surface area

Secondary Outcome

Excursion of diaphragm
Motion speed of diaphragm
Tracheal diameter change
Tracheal narrowing rate
Maximum Pixel Change Rate
Pulmonary function testing
BDI/TDI score
CAT score
Frequency of adverse events
Equipment malfunction
ventilation, perfusion, ventilation-perfusion ratio
Chest CT parameters

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Ikari Jun
• Source(s) of Monetary Support: Nippon Boehringer lngelheim Co. Ltd.