UMIN-CTR Clinical Trial

Basic information
Public title	Genetic analysis research in patients with asthma and chronic cough
Acronym	Genetic analysis research in patients with asthma and chronic cough
Scientific Title	Genetic analysis research in patients with asthma and chronic cough
Scientific Title:Acronym	Genetic analysis research in patients with asthma and chronic cough
Region	Japan

Condition
Condition	asthma and chronic cough
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate genes related to pathophysiology and intractableness of asthma and chronic cough.
Basic objectives2	Others
Basic objectives -Others	To investigate genes related to small airway inflammation and capsaicin cough reflex sensitivity in patients with asthma and chronic cough.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify associations between some genes and refractory asthma and chronic cough.
Key secondary outcomes

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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with asthma and chronic cough aged 20 years and above, who have been seeing their doctors for at least 1 year.
Key exclusion criteria	Patients with asthma and chronic cough aged 19 years and below who continued to see their doctors for less than 1 year
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Fukumitsu Middle name Last name Kensuke
Organization	Nagoya City University
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.
TEL	052-853-8216
Email	k-fkmt@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Fukumitsu Middle name Last name Kensuke
Organization	Nagoya City University
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.
TEL	052-853-8216
Homepage URL
Email	k-fkmt@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical research management center
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.
Tel	052-858-7215
Email	clinical_research@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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 05 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	2020 Year 07 Month 03 Day
Date of IRB	2020 Year 07 Month 14 Day
Anticipated trial start date	2021 Year 03 Month 05 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	Genes will be analyzed in university of Shizuoka. We are preparing that this study will be held in multicenter.

Management information
Registered date	2021 Year 03 Month 05 Day
Last modified on	2021 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049579