UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019570 |
|---|---|
| Receipt number | R000022625 |
| Scientific Title | Health Survey for Chronic Obstructive Pulmonary Disease (COPD) patients |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2019/11/08 14:23:52 |
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Basic information
Public title
Health Survey for Chronic Obstructive Pulmonary Disease (COPD) patients
Acronym
Health Survey for Chronic Obstructive Pulmonary Disease (COPD) patients
Scientific Title
Health Survey for Chronic Obstructive Pulmonary Disease (COPD) patients
Scientific Title:Acronym
Health Survey for Chronic Obstructive Pulmonary Disease (COPD) patients
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Investigation for underlying patients with COPD, which at presence has not been diagnosed with asthma or COPD.
2. Situation of medical care of the COPD patients, and research on differences in the recognition of doctors and patients to COPD.
3. Comparison of the first group and the second group.
Basic objectives2
Others
Basic objectives -Others
Support the early diagnosis and treatment in improving the awareness of COPD
Promotion of appropriate treatment of COPD
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine the proportion of COPD patients who are potentially using the screening questionnaire (COPD-PS).
To examine the deviation of the recognition between doctors and patients by questionnaire
Comparison of the first group and the second group.
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
1. Patients over 40 years old are not diagnosed with asthma or COPD
2. Patients with COPD
Key exclusion criteria
none
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Japan Physicians Association
Division name
Medical Affairs
Zip code
101-0062
Address
2-5 Kandasurugadai Chiyoda-ku, Tokyo, 100-0003 Japan
TEL
03-3259-6110
jpa@nichirinnai.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Setoyama |
Organization
Japan Physicians Association
Division name
Secretariat
Zip code
101-0062
Address
2-5 Kandasurugadai Chiyoda-ku, Tokyo, 100-0003 Japan
TEL
03-3259-6110
Homepage URL
setoyama@nichirinnai.jp
Sponsor or person
Institute
Japan Physicians Association
Institute
Department
Personal name
Funding Source
Organization
KYORIN Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokenikyokai IRB
Address
2-23-2 Turuya-cho Kanagawa-ku Yokohama-shi
Tel
045-313-2111
katsumata.t@doc-net.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
日本臨床内科医会会員の医療施設(全国)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
918
Results
Of the 1,156 responses obtained, 918 valid responses were analyzed. Three hundred and sixty-nine patients (40.2%) had possible COPD (COPDPSB4) and 102(11.1%) had severe symptoms (CATB10). The high-risk group identified by COPD-PS included smokers, patients aged 75 years or older and those with heart disease. It was suggested that a certain proportion of patients may have undiagnosed COPD and that approximately 10% have unrecognized COPD-equivalent symptoms.
Results date posted
| 2019 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 12 | Month | 10 | Day |
Baseline Characteristics
Patients aged 40 years or over visiting primary care physicians for the management of lifestyle-related diseases, etc.,
Participant flow
Patients were screened using the COPD Population Screener(COPD-PS) and COPD Assessment Test(CAT).
Adverse events
none
Outcome measures
COPD Population Screener(COPD-PS) and COPD Assessment Test(CAT)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 10 | Day |
Other
Other related information
Subjects are enrolled sequentially in each sites.
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2019 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022625
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/05/09 | 150817 COPD患者実態調査実施計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/05/09 | COPD患者実態調査.pdf |
