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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025669
Receipt No. R000027550
Scientific Title A cross sectional study of subtypes of cholinergic uriticaria and bronchial hyperresponsiveness
Date of disclosure of the study information 2017/01/13
Last modified on 2019/11/15

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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 Open public recruiting
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
2019 Year 11 Month 15 Day


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

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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