UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009821 |
|---|---|
| Receipt number | R000011412 |
| Scientific Title | Airway biomarkers and air pollution in patients with asthma and other airway diseases |
| Date of disclosure of the study information | 2013/01/22 |
| Last modified on | 2020/01/16 10:59:43 |
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Basic information
Public title
Airway biomarkers and air pollution in patients with asthma and other airway diseases
Acronym
Airway biomarkers and pollution
Scientific Title
Airway biomarkers and air pollution in patients with asthma and other airway diseases
Scientific Title:Acronym
Airway biomarkers and pollution
Region
| Japan |
Condition
Condition
bronchial asthma and other respiratoroy diseaseas, sharing some clinical manifestation.
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We so far demonstrated that Nrf-1, or a transcription factor regulating expression of anti-oxidant-associated genes, is a good biomarker for airway inflammation, and that it is associated with environmental pollution. The aim of this study is to clarify how these baiomarkers, polymorphism of anti-oxidant genes, and environmental pollution are associated with pathogenesis of asthma and other airway disaeses.
Basic objectives2
Others
Basic objectives -Others
Effect of air pollution on the airway is to be evaluated: biomarkers for cytokines, growth factors, and oxidative stress in exhaled breath condensates and blood, are measured. In addtion, polymorphisms of genes responding to oxidative stress are determined. It is also defined how much environmental air is polluted in participants' residential area. General and clinical indicators of asthma and its control are also evaluated. By assessing these biomarkers and data togeter, the study aims at description of how environmental air affect the airway inflammation, and of which is associated with development of asthma or other diseases.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Air pollution
(2) general assessment of asthma and airway inflammation
(3) genetic polymorphism
Association between them is investigated.
Key secondary outcomes
In addition to the above mentioned intems, the following items is investigated, indcluidng
(1) mediators in EBC
(2) mediators in blood
(3) oxidative stress of EBC and blood
(4) inflammatory biomarkers
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
Participants are those who were already diagnosed or suspected with asthma, those who chronically complain respiratory symptoms such as cough, those who were allergic with no symptoms, and those who might be other diseases with respiratopry symptoms including COPD, lung cancer and disseminated lung diseases, as well as healthy individuals. In this process, internationa primary care airway group (IPAG) quesstionairres and other questionnairres will be utilized. They should be twenty years old or over and give informed consent on the basis that the study is approved by each local ethics committee.
Key exclusion criteria
Those whe are dianosed with pulmonary infection, severe cardiologic, hepatic and/or renal issues, are to be excluded. This decision is to be made according by physicians in charge.
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Takizzawa |
Organization
Kyorin University School of Medicine
Division name
Department of Respiratyry Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
htakizawa-alg@umin.ac.jp
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, Tokyo
TEL
0422-47-5511
Homepage URL
irb@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Shool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2013 | Year | 01 | Month | 22 | 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
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
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 22 | 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
This study is cross-sectional prospective observational one, which is intended to clarify how air pollution induces airway inflammation, and, what is more, how genetic polymorphism modifies it.
Management information
Registered date
| 2013 | Year | 01 | Month | 20 | 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=R000011412
