UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017653 |
|---|---|
| Receipt number | 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 09:11:48 |
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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
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
masato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Kyorin University School of Medicine
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
Teikyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020296
