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

Email

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


Email

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

Email

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