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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027735
Receipt No. R000031777
Scientific Title The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine using Astograph method
Date of disclosure of the study information 2017/06/13
Last modified on 2017/06/13

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Basic information
Public title The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine using Astograph method
Acronym The time course of bronchoconstriction triggered cough reaction induced by Methacholine
Scientific Title The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine using Astograph method
Scientific Title:Acronym The time course of bronchoconstriction triggered cough reaction induced by Methacholine
Region
Japan

Condition
Condition cough variant asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine using Astograph method
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 day1 The measurement of cough response to bronchoconstriction induced by Methacholine using Astograph method
day2 The measurement of cough response to bronchoconstriction induced by Methacholine using Astograph method (Investigation the reproducibility)
In day2, we compare the concentration of lipid mediators in the exhaled breath condensate between before and after methacholine inhalation.
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 Male and female healthy subjects >= 20 years of age are eligible for inclusion.
No symptom and history of respiratory disease, cardiovascular disease, gastrointestinal disease, hepatobiliar-pancreatic disease, endocrine and metabolic disease, hematological and malignant disease, renal disease, neuromuscular disease, collagen disease, autoimmune disease, psychosomatic and mental disorder, chronic infectious disease, obstetric and gynecological disease, urological disease, cerebral nervous disease.
Key exclusion criteria Key exclusion criteria were: tachyarrhythmia, heart failure; women of childbearing potential or of breast-feeding; mental disorder or psychiatric symptom; several medical conditions prohibiting partitipation.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Johsuke Hara
Organization Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name Department of Respiratory Medicine
Zip code
Address 13-1 Takara-machi Kanazawa Ishikawa
TEL 076-265-2000
Email hara0728@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Johsuke Hara
Organization Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name Department of Respiratory Medicine
Zip code
Address 13-1 Takara-machi Kanazawa Ishikawa
TEL 076-265-2000
Homepage URL
Email hara0728@gmail.com

Sponsor
Institute Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 13 Day
Last modified on
2017 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031777

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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