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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019350
Receipt No. R000022366
Scientific Title Association of the pathophysiology of chronic cough refractory to specific treatments with levels of hydrogen sulfide(H2S) in serum and sputum supernatant
Date of disclosure of the study information 2015/10/14
Last modified on 2020/07/09

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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/ctr_e/ctr_view.cgi?recptno=R000022366

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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