UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040632 |
|---|---|
| Receipt number | R000046372 |
| Scientific Title | The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma |
| Date of disclosure of the study information | 2020/06/02 |
| Last modified on | 2020/06/02 19:33:35 |
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Basic information
Public title
The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Acronym
The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Scientific Title
The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Scientific Title:Acronym
The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of TRPV1 expression on airway inflammatory cells with severe asthma
Basic objectives2
Others
Basic objectives -Others
To investigate the association of TRPV1 expression on airway inflammatory cells with capsaicin cough refex sensitivity, blood eosinophil/neutrophil counts, FeNO, and pulmonary function.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the association of TRPV1 expression on airway inflammatory cells with severe asthma
Key secondary outcomes
To investigate the association of TRPV1 expression on airway inflammatory cells with capsaicin cough refex sensitivity, blood eosinophil/neutrophil counts, FeNO, and pulmonary function.
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 asthma who underwent sputum induction test and capsaicin cough challenge test from September 2015 to March 2020.
2. Healthy subjects who participated in the study registered on the UMIN Clinical Trials Registry (Registry ID UMIN000018672).
Key exclusion criteria
None
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code
4678601
Address
1 kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528538216
kaney32@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code
4678601
Address
1 kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528538216
Homepage URL
kaney32@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of the Japanese government (20K17219)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
0538537215
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
| 2020 | Year | 06 | Month | 02 | 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
90
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046372
