UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043876 |
|---|---|
| Receipt number | R000050091 |
| Scientific Title | A study on childhood asthma control levels and lung growth disorders |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2022/06/29 07:12:20 |
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Basic information
Public title
Does asthma condition in childhood affect lung growth?
Acronym
Childhood asthma and lung growth
Scientific Title
A study on childhood asthma control levels and lung growth disorders
Scientific Title:Acronym
Childhood asthma and lung growth disorders
Region
| Japan |
Condition
Condition
childhood asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using Omuta pollution-certified chronic respiratory disease patient data, we will examine the effect of Japanese pediatric asthma control levels on lung growth disorders.
Basic objectives2
Others
Basic objectives -Others
Using Omuta pollution-certified chronic respiratory disease patient data, we will examine the effect of Japanese pediatric asthma control levels on progression to non-smoking COPD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
data of lung function
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
| 1 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
asthma
Key exclusion criteria
smokers
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume Univeristy
Division name
Department of Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume
TEL
0942317560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotaka |
| Middle name | |
| Last name | Kawayama |
Organization
Kurume University
Division name
Department of Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume
TEL
0942317560
Homepage URL
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
KAKEN
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University
Address
67 Asahimachi, Kurume
Tel
0942353311
kaneko_fumi@kurume-u.ac.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
| 2021 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
516
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
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 01 | Day |
Other
Other related information
Subjects will enroll by opt-out method
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050091
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/06/29 | 2_研究計画書_大牟田公害と肺発育障害_12282020.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
