UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024734 |
|---|---|
| Receipt number | R000028458 |
| Scientific Title | Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients |
| Date of disclosure of the study information | 2016/11/07 |
| Last modified on | 2021/03/31 09:10:49 |
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Basic information
Public title
Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Acronym
Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Scientific Title
Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Scientific Title:Acronym
Comprehensive study of new biomarkers and physiological indicators in asthmatic or chronic cough patients
Region
| Japan |
Condition
Condition
Asthmatic or chronic cough patients
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the biomarkers or physiological indicators that reflect the pathogenesis of asthma or chronic cough
Basic objectives2
Others
Basic objectives -Others
To establish the biomarkers or physiological indicators that reflect the pathogenesis of asthma or chronic cough
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference between the mean values of the serum biomarkers in asthmatic patients classified according to severity
Key secondary outcomes
The correlation between the value of serum biomarkers and the clinical indicators including respiratory function tests, fractional exhaled NO, nasal NO, airway hyperresponsiveness, cough sensitivity, induced sputum, chest CT, paranasal sinus CT and tissue specimens in asthmatic or chronic cough patients
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult asthmatic or chronic cough peatients including current smoking or regular use of oral corticosteroids
Key exclusion criteria
1. Patients with ischemic heart disease, interstitial lung disease, collagen disease or malignant tumors
2. Patients who cannot obtain informed consent
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University 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, Aichi, Japan
TEL
+81-52-853-8216
kaney32@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University 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, Aichi, Japan
TEL
+81-52-853-8216
Homepage URL
kaney32@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University School of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Daido hospital and daido clinic
Banbuntane houtokukai hospital
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
052-853-8348
irb_jimu@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
名古屋市立大学病院（愛知県）、大同病院・だいどうクリニック（愛知県）、藤田保健衛生大学坂文種報徳會病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design
Observational study
Management information
Registered date
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028458
