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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019257
Receipt No. 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 2019/10/09

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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
Middle name
Last name Imaizumi Kazuyoshi
Organization Fujita Health University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan
TEL 81-562-93-2111
Email jeanluc@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isogai Sumito
Organization Fujita Health University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan
TEL 0562-93-2111
Homepage URL
Email hirosimax2000@yahoo.co.jp

Sponsor
Institute Department of Respiratory Medicine, Fujita Health University of Medicine
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
Address
Tel
Email

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 藤田医科大学医学部付属病院

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 09 Month 30 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
2019 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022265

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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