UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059674 |
|---|---|
| Receipt number | R000068260 |
| Scientific Title | Study of Type 2 inflammatory COPD |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 07:54:59 |
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Basic information
Public title
A study on the significance of Type 2 inflammation in chronic obstructive pulmonary disease (COPD) using data from the TRACK study
Acronym
Study of Type 2 inflammatory COPD
Scientific Title
Study of Type 2 inflammatory COPD
Scientific Title:Acronym
Study of Type 2 inflammatory COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the clinical significance of type 2 inflammatory phenotype stratification in Japanese COPD patients and to verify whether this phenotype stratification can serve as a selection criterion for anti-inflammatory treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study aims to investigate the clinical characteristics of COPD patients with elevated eosinophil levels.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD patients participating in the TRACK study
Key exclusion criteria
none
Target sample size
572
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University
Division name
Department of medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume
TEL
0942317560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoataka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University
Division name
Department of medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume
TEL
0942317560
Homepage URL
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Kurume University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University Clinical Research Center
Address
67 Asahi-machi, Kurume
Tel
0942317200
i_rinri@kurume-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-06-R-07
Org. issuing International ID_1
Saga University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 07 | 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
572
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collaboration between Saga University, Kagoshima University, and the University of Occupational and Environmental Health
Post-hoc study
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068260
