UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.
Title of the study (Brief title)	Identification of lettuce allergen and investigation of atopic and asthmatic diathesis related to lettuce-induced asthma.
Region	Japan

Condition
Condition	asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify casual protein of lettuce induced asthma.
Basic objectives2	Others
Basic objectives -Others	To estimate the symptom of lettuce induced asthma.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of casual protein of lettuce induced asthma.
Key secondary outcomes	Atopic diathesis of lettuce-induced asthma patients. skin prick test, blood test, lettuce-specific inhalation test, peak flow.

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	The patients who have respiratory symdrome related to lettuce at Awaji prefectual hospital
Key exclusion criteria	none
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Kamiryo
Organization	Kobe University Hospital
Division name	Division of Respiratory Medicine
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5660
Email	hiroshio@med.kobe-u.ac.jp

Public contact
Name of contact person	Tatsuya Nagano
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5660
Homepage URL
Email	tnagano@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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	兵庫県立淡路医療センター/Hyogo Prefectural Awaji Medical center

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 17 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 21 Day
Anticipated trial start date	2016 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Skin prick test,blood test, and Lettuce-specific inhalation test will be performed.

Management information
Registered date	2017 Year 04 Month 15 Day
Last modified on	2017 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029570