UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019350 |
|---|---|
| Receipt number | 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 00:57:05 |
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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
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
k-fkmt@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Dept of Respiratory Medicine, Allergy and Clinical Immunology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022366
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
