UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013998 |
|---|---|
| Receipt number | R000016308 |
| Scientific Title | Analysis of patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2021/05/24 11:52:03 |
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Basic information
Public title
Analysis of patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Acronym
Analysis of patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Scientific Title
Analysis of patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Scientific Title:Acronym
Analysis of patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Region
| Japan |
Condition
Condition
Patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of patient with patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Basic objectives2
Others
Basic objectives -Others
Analysis of clinical condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ten patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator
Key exclusion criteria
Patient with psychiatric disease, diagnosed disorder provide cause of chest pain, pregnant female, lactating woman, and side effect profile of montelukast, procaterol , nitroglycerin, omeprazole
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Toyama Prefectural Central Hospital
Division name
The Department of Internal Medicine
Zip code
930-8550
Address
2-2-78 Nishinage, Toyama-city, Toyama 930-8550, Japan
TEL
+81.76.424.1531
tan-tym@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Taniguchi |
Organization
Toyama Prefectural Central Hospital
Division name
The Department of Internal Medicine
Zip code
930-8550
Address
2-2-78 Nishinage, Toyama-city, Toyama 930-8550, Japan
TEL
+81.76.424.1531
Homepage URL
tan-tym@umin.ac.jp
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama Prefectural Central Hospital/ Ethics committee
Address
2-2-78 Nishinage, Toyama-city, Toyama 930-8550, Japan
Tel
+81.76.424.1531
tan-tym@umin.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
| 2014 | Year | 06 | Month | 01 | 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
| 2010 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of patients presenting without an asthma attack but having persistent or recurrent chest tightness that improved in response to asthma drugs without a bronchodilator. Peripheral blood eosinophils, specific and non-specific IgE, pulmonary function test, bronchodilator test, airway hyper reactivity test, trans-bronchial bronchus biopsy, sputum eosinophils, and exhaled air NO.
Management information
Registered date
| 2014 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
