UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025669 |
|---|---|
| Receipt number | 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 | 2021/01/24 12:57:58 |
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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
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
tnagano@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027550
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
