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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000040632 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Asthma | ||
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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). |
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Key exclusion criteria | None | |||
Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan |
Institute | |
Department |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Retrospective study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046372 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |