UMIN-CTR Clinical Trial

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 Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University School of Medical Sciences
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code	4678601
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 Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University School of Medical Sciences
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code	4678601
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	Nagoya City University
Address	1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
Tel	052-853-8348
Email	irb_jimu@med.nagoya-cu.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	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	Partially published

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	2016 Year 11 Month 07 Day
Anticipated trial start date	2016 Year 11 Month 07 Day
Last follow-up date	2024 Year 03 Month 31 Day
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	2021 Year 03 Month 31 Day

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