UMIN-CTR Clinical Trial

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

Sponsor
Institute	Department of Respiratory Medicine Kyorin University hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006901