UMIN-CTR Clinical Trial

Basic information
Public title	Association of the pathophysiology of chronic cough refractory to specific treatments with levels of hydrogen sulfide(H2S) in serum and sputum supernatant
Acronym	Association of the pathophysiology of chronic cough refractory to specific treatments with levels of hydrogen sulfide(H2S) in serum and sputum supernatant
Scientific Title	Association of the pathophysiology of chronic cough refractory to specific treatments with levels of hydrogen sulfide(H2S) in serum and sputum supernatant
Scientific Title:Acronym	Association of the pathophysiology of chronic cough refractory to specific treatments with levels of hydrogen sulfide(H2S) in serum and sputum supernatant
Region	Japan

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

Objectives
Narrative objectives1	To measure the concentration of hydrogen sulfide in serum and sputum supernatant in asthmatics and non-asthmatics refractory to specific treatments
Basic objectives2	Others
Basic objectives -Others	To measure the concentration of hydrogen sulfide in serum and sputum supernatant in asthmatics and non-asthmatics refractory to specific treatments
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Elevated levels of H2S would associate with the pathophysiology of chronic cough refractory to specific treatments
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	16 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	Group(a) Patients with asthmatic cough lasting for 8 weeks or more despite receving adequate therapies Group(b) Patients with asthmatic cough whose cough is well-controlled Group(c) Patients with non-asthmatic cough lasting for 8 weeks or more despite receving specific therapies Group(d) Controll subjects
Key exclusion criteria	If patients meet the following criteria, they are excluded. Patients who have other respiratory disease such as tuberculosis and lung cancer currently smoke, had smoking history with 10 pack-years or more, or had quitted smoking within 6 months prior to the enrollment
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University
Division name	Dept of Respiratory Medicine, Allergy and Clinical Immunology
Zip code	4678601
Address	1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
TEL	052-853-8216
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
Division name	Dept of Respiratory Medicine, Allergy and Clinical Immunology
Zip code	4678601
Address	1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
TEL	052-853-8216
Homepage URL
Email	k-fkmt@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology
Institute
Department

Funding Source
Organization	Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	052-858-7215
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	2015 Year 10 Month 14 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	113
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Serum or sputum supernatant hydrogen sulfide were similar between patients with persistent cough and those without cough. We are plannnig a new research plan using optout for patients who have already measured serum or sputum supernatant hydrogen sulfide.
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	Completed
Date of protocol fixation	2015 Year 09 Month 29 Day
Date of IRB	2015 Year 09 Month 29 Day
Anticipated trial start date	2015 Year 10 Month 21 Day
Last follow-up date	2018 Year 09 Month 29 Day
Date of closure to data entry	2018 Year 09 Month 29 Day
Date trial data considered complete	2018 Year 09 Month 29 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	Design cross-sectional study Enrollment patients who met the criteria of this study will be enrolled between Oct 2015 and Sep 2018 Measurement items levels of H2S in serum and sputum supernatant

Management information
Registered date	2015 Year 10 Month 14 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022366