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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017653
Receipt No. R000020296
Scientific Title A survey research for predicting patients of bronchial asthma with high-sensitivity against air pollution materials including particle matter (PM 2.5) and establishing a healthcare system to prevent exacerbation
Date of disclosure of the study information 2015/06/01
Last modified on 2016/05/22

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Basic information
Public title A survey research for predicting patients of bronchial asthma with high-sensitivity against air pollution materials including particle matter (PM 2.5) and establishing a healthcare system to prevent exacerbation
Acronym Air pollution sensitivity and health care in patients with bronchial asthma
Scientific Title A survey research for predicting patients of bronchial asthma with high-sensitivity against air pollution materials including particle matter (PM 2.5) and establishing a healthcare system to prevent exacerbation
Scientific Title:Acronym Air pollution sensitivity and health care in patients with bronchial asthma
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Medicine in general Pneumology Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1. Prediction of patients with bronchial asthma with high-sensitivity against air pollution material including fine particle matter (PM2.5).
2. Estimation of health care administration method to prevent exacerbation.
Basic objectives2 Others
Basic objectives -Others Prospective observation and intervention trial.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Quality of life
Key secondary outcomes Biomarkers (blood, exhaled breath condensate and sputum)
Antioxidation-associated gene polymorphism
Respiratory function

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Standard drug therapy with healthcare administration followed by standard drug therapy
Interventions/Control_2 Standard drug therapy followed by standard drug therapy with healthcare administration
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
Patients with respiratory symptom and allergy but do not show typical phenotype of bronchial asthma
Patient with lung diseases (e.g. diffuse lung diseases, COPD, lung cancer, etc.)
Key exclusion criteria Patients with apparent infection
Patients with severe heart disease, liver disease, or renal disease
Patients whom attending physician advised not to entry
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Takizawa
Organization Kyorin University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Shinkawa 6-20-2, Mitakashi, Tokyo, 181-8611, Japan
TEL +81-422-47-5511
Email htakizawa.alg@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masato Watanabe
Organization Kyorin University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Shinkawa 6-20-2, Mitakashi, Tokyo, 181-8611, Japan
TEL +81-422-47-5511
Homepage URL
Email masato@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Kyorin University School of Medicine
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
Teikyo University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 22 Day
Last modified on
2016 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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