Skip to content

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

Examination of the usefulness of a dynamic flat-panel detector system for patients with chronic pulmonary obstructive disease under the treatment with Tiotropium/Olodaterol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210543
Enrollment
35
Registered
2022-01-11
Start date
2022-08-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease Dynamic-Ventilatory Digital Radiography,COPD,tiotropium/olodaterol

Interventions

Conducting X-ray dynamic image inspection by a dynamic flat-panel detector system, chest CT, administration of tiotropium/olodaterol
D013902, D061330, C000611386
X-ray dynamic image inspection by a dynamic flat-panel detector system, chest CT, tiotropium/olodaterol

Sponsors

Ikari Jun
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Rate of change in surface area

Secondary

MeasureTime frame
Excursion of diaphragm Motion speed of diaphragm Diaphragmatic excursion time Tracheal diameter change Tracheal narrowing rate Maximum Pixel Change Rate Pulmonary function testing BDI/TDI score CAT score Parameters derived from lung surface area Frequency of adverse events Equipment malfunction

Contacts

Public ContactJun Ikari

Chiba university hospital

junikari@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026