UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005937 |
|---|---|
| Receipt number | R000006901 |
| Scientific Title | Elucidation of the association between airway inflammation, of both asthmatics and non-asthmatics, and stimulants from air pollutants. |
| Date of disclosure of the study information | 2011/07/07 |
| Last modified on | 2020/01/16 10:41:59 |
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Basic information
Public title
Elucidation of the association between airway inflammation, of both asthmatics and non-asthmatics, and stimulants from air pollutants.
Acronym
Elucidation of the factors that cause airway inflammation.
Scientific Title
Elucidation of the association between airway inflammation, of both asthmatics and non-asthmatics, and stimulants from air pollutants.
Scientific Title:Acronym
Elucidation of the factors that cause airway inflammation.
Region
| Japan |
Condition
Condition
bronchial asthma, other airway/ pulmonary diseaseas
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether or not the onset of asthma is associated to theits onset and the air pollution exposure.
Basic objectives2
Others
Basic objectives -Others
To clarify how air pollution contributes to the pathogenesis of bronchial asthma.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
It is to be elucidated whether or not the association between biomarkers in expiratory breath condensation (EBC) and the levels of airpollution.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with bronchial asthma,those who yield airway symptoms and/or positive allergic reaction but do not develop asthma,and healthy controls,on the basis of patients'informed consent,as well as of the approval of the local ethics committee,are to be enrolled.
Key exclusion criteria
Those who develop lung infections,critical cardiovascular disorders,liver diseases,renal diseases,according to the diagnosis by the clinicians in charge,are to be excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Takizawa |
Organization
Kyorin University Hospital
Division name
Department of Respiratory Medicine
Zip code
181-8611
Address
6-20-2,Shinkawa,Mitaka-shi,Tokyo 181-8611 JAPAN
TEL
0422-47-7377
htakizawa.alg@gmail.com
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Tabata |
Organization
Kyorin University
Division name
Ethical Committee
Zip code
181-8611
Address
6-20-2,Shinkawa,Mitaka-shi,Tokyo 181-8611 JAPAN
TEL
0422-47-5511
Homepage URL
irb@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine
Kyorin University hospital
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The university of Tokyo hospital
Teikyo University School of medicine University Hospital, Mizonokuchi
Nippon medical school hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University
Address
6-20-2,Shinkawa,Mitaka-shi,Tokyo 181-8611 JAPAN
Tel
0422-47-5511
irb@ks.kyorin-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
| 2011 | Year | 07 | 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
106
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
| 2011 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
relationship between air pollution and airway inflammatory responses in each patient with asthma and related disorders
a prospective, cohort study
Management information
Registered date
| 2011 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006901
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
