UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the prevalence and risk factors of eosinophilic esophagitis in patients with bronchial asthma
Title of the study (Brief title)	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	Yoshikazu Kinoshita
Organization	Shimane university faculty of medicine
Division name	second department of internal medicine
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	Yoshikazu Kinoshita
Organization	Shimane university faculty of medicine
Division name	second department of internal medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 11 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011489