UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019257 |
|---|---|
| Receipt number | R000022265 |
| Scientific Title | Gradual change in methacholine bronchial hyperresponsiveness in bronchial asthma patient population |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2025/04/16 10:19:16 |
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Basic information
Public title
Gradual change in methacholine bronchial hyperresponsiveness in bronchial asthma patient population
Acronym
Gradual change in methacholine
bronchial hyperresponsiveness
Scientific Title
Gradual change in methacholine bronchial hyperresponsiveness in bronchial asthma patient population
Scientific Title:Acronym
Gradual change in methacholine
bronchial hyperresponsiveness
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of gradual changes in the first methacholine hyperresponsiveness test in bronchial asthma
Basic objectives2
Others
Basic objectives -Others
Prospective observation and intervention trial.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
gradual change of methacholinPC-20(provocative concentration that results in a 20% fall in FEV1) in first methacholine hyperresponsiveness test
Key secondary outcomes
asthma medications, bronchial asthma severity before methacholine hyperresponsiveness 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with bronchial asthma
Bronchial asthma patients who underwent the first methacholine airway hyperresponsiveness test
Key exclusion criteria
Patients with apparent infection
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Imaizumi |
| Middle name | |
| Last name | Kazuyoshi |
Organization
Fujita Health University of Medicine
Division name
Department of Respiratory Medicine
Zip code
4701192
Address
Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan
TEL
81-562-93-2111
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Isogai |
| Middle name | |
| Last name | Sumito |
Organization
Fujita Health University of Medicine
Division name
Department of Respiratory Medicine
Zip code
470-1192
Address
Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2111
Homepage URL
hirosimax2000@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Fujita Health University of Medicine
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
Department of Respiratory Medicine
Address
Dengakugakubo 1-98, Kutsukakecho, Toyoake, Aichi 470-1192, Japan.
Tel
81-562-93-2111
isogai@fujita-hu.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
藤田医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 07 | 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
| 2015 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
gradual change of methacholinPC-20(provocative concentration that results in a 20% fall in FEV1) in first methacholine hyperresponsiveness test.
All subjects that our hospital is visited by bronchial asthma, and underwent methacholine hyperresponsiveness test, met the selection criteria. The implementation period is October 7, 2015 - March 31, 2025.
Measurement items methacholine is airway hyperresponsiveness test , before therapeutic drugs, smoking history and bronchial asthma severity.
We investigate them by medical records.
Management information
Registered date
| 2015 | Year | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022265
