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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024734
Receipt No. R000028458
Scientific Title Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Date of disclosure of the study information 2016/11/07
Last modified on 2016/11/07

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Basic information
Public title Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Acronym Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Scientific Title Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Scientific Title:Acronym Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Region
Japan

Condition
Condition Asthmatic or chronic cough patients
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the biomarkers or physiological indicators that reflect the pathogenesis of asthma or chronic cough
Basic objectives2 Others
Basic objectives -Others To establish the biomarkers or physiological indicators that reflect the pathogenesis of asthma or chronic cough
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference between the mean values of the serum biomarkers in asthmatic patients classified according to severity
Key secondary outcomes The correlation between the value of serum biomarkers and the clinical indicators including respiratory function tests, fractional exhaled NO, nasal NO, airway hyperresponsiveness, cough sensitivity, induced sputum, chest CT, paranasal sinus CT and tissue specimens in asthmatic or chronic cough patients

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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Adult asthmatic or chronic cough peatients including current smoking or regular use of oral corticosteroids
Key exclusion criteria 1. Patients with ischemic heart disease, interstitial lung disease, collagen disease or malignant tumors
2. Patients who cannot obtain informed consent
Target sample size 750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Kanemitsu
Organization Nagoya City University School of Medical Sciences
Division name Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address 1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
TEL +81-52-853-8216
Email kaney32@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Kanemitsu
Organization Nagoya City University School of Medical Sciences
Division name Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
Address 1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
TEL +81-52-853-8216
Homepage URL
Email kaney32@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University School of Medical Sciences
Institute
Department

Funding Source
Organization Nagoya City University School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Daido hospital and daido clinic
Banbuntane houtokukai hospital
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 名古屋市立大学病院(愛知県)、大同病院・だいどうクリニック(愛知県)、藤田保健衛生大学坂文種報徳會病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design
Observational study

Management information
Registered date
2016 Year 11 Month 07 Day
Last modified on
2016 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028458

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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