UMIN-CTR Clinical Trial

Basic information
Public title	Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Acronym	Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Scientific Title	Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Scientific Title:Acronym	Long-term change in capsaicin cough reflex sensitivity with asthma treatments
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the association of long-term change in capsaicin cough reflex sensitivity with treatment intervention in patients with asthma.
Basic objectives2	Others
Basic objectives -Others	To evaluate the association of the change in capsaisin cough reflex sensitivity with asthma control and severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate long-term change in capsaicin cough reflex sensitiviy (1 to 5 years) with asthma treatment in the stratification with severe and non-severe asthma.
Key secondary outcomes	To determine the improvement of capsaicin cough sensitivity by biologic agents.

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	asthma and cough-variant asthma
Key exclusion criteria	Those who have other respiratory disease Those who are pregnant
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University Graduate 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
TEL	0528538216
Email	kaney32@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Fukumitsu
Organization	Nagoya City University Graduate 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
TEL	0528538216
Homepage URL
Email	k-fkmt@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology of the Japanese government
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	Nagoya City University Clinical research center
Address	1 kawasumi, mizuho-cho, mizuho-ku,Nagoya
Tel	0538537215
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	2020 Year 04 Month 21 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 04 Month 21 Day
Date of IRB	2020 Year 07 Month 21 Day
Anticipated trial start date	2020 Year 07 Month 21 Day
Last follow-up date	2026 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate the association of long-term change in capsaicin cough reflex sensitivity with asthma control and severity in patients with asthma.

Management information
Registered date	2020 Year 04 Month 21 Day
Last modified on	2021 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045867