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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009815
Receipt No. R000011489
Scientific Title Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Date of disclosure of the study information 2013/02/01
Last modified on 2019/02/08

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Basic information
Public title Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Acronym Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Scientific Title Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Scientific Title:Acronym Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Region
Japan

Condition
Condition eosinophilic esophagitis
bronchial asthma
Classification by specialty
Gastroenterology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the prevalence rate of the eosinophilic esophagitis among the patients with bronchial asthma and the risk factors of developing the disease
Basic objectives2 Others
Basic objectives -Others prevalence rate
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes prevalence rate of the eosinophilic esophagitis among the patients with bronchial asthma
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 gastrointestinal fiberscopy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with bronchial asthma diagnosed by pulmonary physician.
written informed concent.
Key exclusion criteria receiving systemic glucocorticoids.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane university faculty of medicine
Division name second department of internal medicine
Zip code
Address 89-1, Ennya-Cho, Izumo, Shimane, 693-8501, Jpan
TEL +81-853-20-2190
Email kinosita@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane university faculty of medicine
Division name second department of internal medicine
Zip code
Address 89-1, Ennya-Cho, Izumo, Shimane, 693-8501, Jpan
TEL +81-853-20-2190
Homepage URL
Email kinosita@med.shimane-u.ac.jp

Sponsor
Institute Shimane universitu faculty of medicine
Institute
Department

Funding Source
Organization Shimane university facutly of medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Matsue Red Cross Hospital
Matsue City Hospital
Hamada medical center
Yonago medical center
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 Shimane university Hospital (Shimane)
Matsue Red Cross Hospital (Shimane)
Matsue City Hospital (Shimane)
Hamada medical center (Shimane)
Yonago medical center (Tottori)

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 Terminated
Date of protocol fixation
2012 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 21 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 20 Day
Last modified on
2019 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011489

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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