UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060502 |
|---|---|
| Receipt number | R000069217 |
| Scientific Title | Clinical Significance of ROSE-defined Bronchiectasis in Japanese Patients with Chronic Obstructive Pulmonary Disease: A Single-centre Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/28 18:00:44 |
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Basic information
Public title
Clinical Significance of ROSE-defined Bronchiectasis in Japanese Patients with Chronic Obstructive Pulmonary Disease: A Single-centre Retrospective Cohort Study
Acronym
Significance of the ROSE Criteria in Japanese Patients with COPD
Scientific Title
Clinical Significance of ROSE-defined Bronchiectasis in Japanese Patients with Chronic Obstructive Pulmonary Disease: A Single-centre Retrospective Cohort Study
Scientific Title:Acronym
Significance of the ROSE Criteria in Japanese Patients with COPD
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of the ROSE criteria in Japanese patients with COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to the first COPD exacerbation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) chronic respiratory symptoms consistent with COPD (such as dyspnoea, cough, sputum production, or a history of exacerbations); (2) a relevant exposure history, including cigarette smoking; and (3) confirmation of persistent airflow limitation, defined as a post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio of <0.7 on spirometry.
Key exclusion criteria
(1) age <18 years, (2) concurrent interstitial lung disease to rule out traction BE, and (3) visits primarily for lung cancer treatment to avoid confounding effects on prognosis.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kida |
Organization
National Hospital Organization, Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka-shi, Osaka, Japan
TEL
06-6853-2001
k.hashimoto@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Hashimoto |
Organization
National Hospital Organization, Osaka Toneyama Medical Center
Division name
Department of Respiratory Medicine
Zip code
560-8552
Address
Department of Respiratory Medicine
TEL
06-6853-2001
Homepage URL
k.hashimoto@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
National Hospital Organization, Osaka Toneyama Medical Center
Institute
Department
Personal name
Kazuki Hashimoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization, Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka-shi, Osaka, Japan
Tel
06-6853-2001
410-chiken@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
289
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
his single-centre retrospective cohort study investigated the prognostic significance of ROSE-defined bronchiectasis (BE) in Japanese patients with COPD. Among 289 patients, ROSE-defined BE was less prevalent than radiological BE but was significantly associated with a shorter time to first exacerbation, whereas radiological BE alone was not. This association was particularly evident in patients with mild to moderate COPD (GOLD stages 1-2). These findings suggest that ROSE-defined BE may better identify clinically meaningful BE and predict future exacerbations in COPD than radiological findings alone.
Management information
Registered date
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069217
