UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021365 |
|---|---|
| Receipt number | R000024639 |
| Scientific Title | Observational study on effects of Asian sand dust on health status of COPD patients |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2016/03/30 17:29:17 |
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Basic information
Public title
Observational study on effects of Asian sand dust on health status of COPD patients
Acronym
Effects of Asian sand dust on COPD
Scientific Title
Observational study on effects of Asian sand dust on health status of COPD patients
Scientific Title:Acronym
Effects of Asian sand dust on COPD
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate effects ofAsian sand dust on symptoms and lung function of COPD patients
Basic objectives2
Others
Basic objectives -Others
to explore risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between Asian sand dust and changes of lung function
Key secondary outcomes
Relation between Asian sand dust and changes of symptoms or frequency of acute exacerbation
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
diagnosis of COPD
Key exclusion criteria
1) unable to respond questionnaire
2) unable to measure lung function
3) acute exacerbation within 2 month before enrollment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Yoshida |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL
092-565-5534
myoshida@mfukuoka2.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Yoshida |
Organization
National Hospital Organization Fukuoka Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
4-39-1 Yakatabaru, Minami-ku, Fukuoka 811-1394
TEL
092-565-5534
Homepage URL
myoshida@mfukuoka2.hosp.go.jp
Sponsor or person
Institute
Oita University of Nursing and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health Labour and Welfare, Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 07 | 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
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
| 2010 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: case-series study
Subject recruitment: COPD outpatients regularly visiting National Hospital Organization Fukuoka Hosptal
Recruiting period: from 14 MAR 2012 to 15 MAY 2012
Primary endpoint: relationship between Asian sand dust and lung function
Secondary endpoint: relationship between Asian sand dust and symptoms
Management information
Registered date
| 2016 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024639
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
