UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049532 |
|---|---|
| Receipt number | R000056400 |
| Scientific Title | Epidemiological study of chronic obstructive pulmonary disease (COPD) using health insurance claims data and health examination data |
| Date of disclosure of the study information | 2022/11/16 |
| Last modified on | 2024/05/19 17:13:51 |
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Basic information
Public title
Epidemiological study of chronic obstructive pulmonary disease (COPD) using health insurance claims data and health examination data
Acronym
Epidemiological study of COPD using health insurance claims data and health examination data
Scientific Title
Epidemiological study of chronic obstructive pulmonary disease (COPD) using health insurance claims data and health examination data
Scientific Title:Acronym
Epidemiological study of COPD using health insurance claims data and health examination data
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using health insurance claims data and health examination data, we will investigate the epidemiology of COPD and the characteristics of those with airflow limitation, and the relationship between COPD and frailty and anemia.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of airflow limitation and COPD diagnosis rate
Key secondary outcomes
- Percentage of patients by severity of airflow limitation using %FEV1
- FEV1%, FEV1, prevalence of disease, and prescription drugs by COPD diagnosis
- FEV1%, FEV1, and prevalence of disease by frailty classification
- FEV1% and FEV1 by COPD diagnosis and smoking status over 3 years
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
Target Group (1)
(i) Have had at least one medical checkup between January 2017 and December 2019
(ii) Enrolled for one year in the year of the checkup
(iii) Aged 40 years or older at the time of the checkup
(iv) FEV1% and FEV1 have been measured
Target Group (2)
(i) Have a medical checkup in each year (3 years) from January 2017 to December 2019
(ii) Have been enrolled for three years from January 2017
(iii) Aged 40 years or older as of January 2017
(iv) Have airflow limitation as of 2017
(v) Have had FEV1% and FEV1 measured continuously for 3 years
Key exclusion criteria
No setting
Target sample size
60000
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Koga |
Organization
Kracie, Ltd.
Division name
Pharmaceutical Research Promotion Department, Pharmaceutical Division
Zip code
108-8080
Address
3-20-20, Kaigan, Minato-ku, Tokyo, Japan
TEL
03-5446-3352
koga_yuka@kracie.co.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Koga |
Organization
Kracie, Ltd.
Division name
Pharmaceutical Research Promotion Department, Pharmaceutical Division
Zip code
108-8080
Address
3-20-20, Kaigan, Minato-ku, Tokyo, Japan
TEL
03-5446-3352
Homepage URL
koga_yuka@kracie.co.jp
Sponsor or person
Institute
Kracie, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kracie, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
JMDC Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsa@riversideclinic.or.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
| 2022 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100000
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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study and past-origin cohort study using the JMDC database
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056400
