UMIN-CTR Clinical Trial

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
Email	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
Email	irb@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University Shool of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011412