UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047523 |
|---|---|
| Receipt number | R000054199 |
| Scientific Title | To Control of Refractory Chronic Cough: Approach to Pathological Diversity Using Biomarkers |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/11/09 21:08:02 |
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Basic information
Public title
To Control of Refractory Chronic Cough: Approach to Pathological Diversity Using Biomarkers
Acronym
Exploratory research on the pathophysiology of refractory chronic cough using biomarkers
Scientific Title
To Control of Refractory Chronic Cough: Approach to Pathological Diversity Using Biomarkers
Scientific Title:Acronym
Exploratory research on the pathophysiology of refractory chronic cough using biomarkers
Region
| Japan |
Condition
Condition
chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using biomarkers to clarify the pathophysiology or phenotypes that are predominantly involved in individual patients with chronic cough, we aim to establish treatment selection criteria tailored to each individual patient with chronic cough.
Basic objectives2
Others
Basic objectives -Others
By using biomarkers to clarify the pathophysiology or phenotypes that are predominantly involved in individual patients with chronic cough, we aim to establish treatment selection criteria tailored to each individual patient with chronic cough.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients whose cough VAS has improved by 30 or more or 50% or more from the pretreatment value at 12 weeks after the start of treatment are defined as the responders, and the other patients are defined as non-responders. Comparing clinical characteristics and biomarkers at the baseline between the responders and the non-responders.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with chronic cough in a narrow sense who visited our outpatient department for asthma and chronic cough at the first visit
(2) Patients for whom written consent has been obtained for participation in this study
Key exclusion criteria
(1) Current smokers and past smokers with 20 pack-years or more
(2) Patients with frequent visits who have difficulty following the course
(3) Patients with other obvious respiratory diseases such as lung cancer and interstitial lung disease
(4) Pregnant and lactating patients
(5) Other patients who are judged to be inappropriate as subjects by the principal investigators or the co-investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 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
Mizuhocyo-Kawasumi-1, Nagoya, Japan
TEL
0528538216
k-fkmt@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Uemura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
Mizuhocyo-Kawasumi-1, Nagoya, Japan
TEL
0528538216
Homepage URL
keimaito4869@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital, clinical research center
Address
Mizuhocyo-Kawasumi-1, Nagoya, Japan
Tel
0528515511
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
| 2022 | Year | 04 | Month | 20 | 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
| 2021 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Research Flow]
We will select patients with a narrowly defined chronic cough who are first-time visitors to our outpatient asthma and chronic cough clinic and for whom a cause cannot be easily identified after medical interview, physical examination, and chest X-ray (chest and sinus CT, bronchoscopy, and echocardiography, if necessary). Patients who consent to the study will be evaluated by spirometry, airway reversibility test, peripheral blood eosinophil and neutrophil counts, total and specific IgE levels, exhaled NO measurement, induced sputum test, capsaicin cough receptor sensitivity test, sputum and serum ghrelin levels, serum vitamin B12 and various questionnaires.
Thereafter, after 12 weeks of thorough evaluation and maximum treatment by a specialist physician, the patients will be sorted into "a group of patients whose cough visual analog scale (cough VAS) has improved by 30 or more or by 50% or more from the pre-treatment value" and "other groups" and baseline clinical indices will be compared between the two groups.
Serum and induced sputum supernatants will be frozen and stored at -80. Serum biomarkers (ATP, HMGB-1, hydrogen sulfide, YKL-40, melatonin, CRH, ACTH) and sputum biomarkers (ATP, HMGB-1, hydrogen sulfide, YKL-40, pepsin/bile acids) that may be relevant to the pathogenesis of RCC/UCC patients will also be measured.
Management information
Registered date
| 2022 | Year | 04 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054199
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