UMIN-CTR Clinical Trial

Basic information
Public title	A cross sectional study of subtypes of cholinergic uriticaria and bronchial hyperresponsiveness
Acronym	Cholinergic uriticaria and bronchial hyperresponsiveness
Scientific Title	A cross sectional study of subtypes of cholinergic uriticaria and bronchial hyperresponsiveness
Scientific Title:Acronym	Cholinergic uriticaria and bronchial hyperresponsiveness
Region	Japan

Condition
Condition	Cholinergic urticaria
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the subtype of cholinergic urticaria which is highly associated with bronchial asthma.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Minimum cumulative dose of methacholine (D min) required to increase airway resistance
Key secondary outcomes	Slope of respiratory conductance (S Crs/Grs cont) from the baseline Respiratory symptoms Fractional exhaled nitric oxide (FeNO) Lung function test

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	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Three subtypes of cholinergic urticaria Patients with hyperrsensitivity to sweat with angioedema Patients with hyperrsensitivity to sweat without angioedema Patients with hyperrsensitivity to serum or with hypohidrosis 2.Provided written informed consent
Key exclusion criteria	1.Contraindications of bronchial responsiveness test 2.Patients with uncontrolled asthma under the treatment
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Tastuya Middle name Last name Nagano
Organization	Kobe University Hospital
Division name	Division of Respiratory Medicine
Zip code	650-0017
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	1st name Tatsuya Middle name Last name Nagano
Organization	Kobe University Graduate School of Medicine
Division name	Division of Respiratory Medicine, Department of Internal Medicine
Zip code	650-0017
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	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Kobe University Hospital Clinical Translational Research Center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017
Tel	81-78-382-6669
Email	kansatsu@med.kobe-u.ac.jp

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	2017 Year 01 Month 13 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	Completed
Date of protocol fixation	2016 Year 10 Month 24 Day
Date of IRB	2016 Year 10 Month 25 Day
Anticipated trial start date	2016 Year 11 Month 09 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective study We will measure a bronchial sensitivity to inhaled methacholine by using Astograph, and compare a minimum cumulative dose (D min) required to increase airway resistance in three groups of patients with cholinergic uriticaria.

Management information
Registered date	2017 Year 01 Month 13 Day
Last modified on	2021 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027550