Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 1:37 PM
Study NCT ID:
NCT02591550
Status:
UNKNOWN
Last Update Posted:
2015-10-29
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Mechanism of Cough Hypersensitivity
Sponsor:
Kefang Lai
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is described as follows,
1. To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).
2. To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.
3. To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.
1. To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).
2. To observe the variance of cough reflex sensitivity conducted by transient receptor potential ankyrin 1(TRPA1) of chronic patients and the relationship between cough reflex sensitivity conducted by TRPA1 and conducted by TRPV1.
3. To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.
Detailed Description:
This study is divided into two major part, Firstly,to observe the variance of cough reflex sensitivity of chronic cough patients and the relationship between it and airway inflammation.
1. Recruit chronic cough patients and healthy volunteers as subjects.
2. Help subjects to complete detailed history,physical examination,Hull airway reflux questionnaire,chest x-rays,induced sputum,blood routine test,pulmonary ventilation function test and histamine provocation test before they enter this study.
3. Complete allyl isothiocynate(AITC) cough provocation test the day subjects enter the study,then complete capsaicin（CAP）cough provocation test after 3 days.
4. To detect the substance P(SP),calcitonin gene-related peptide(CGRP),prostaglandin E2(PGE2),et al level in sputum supernatants.
Secondly,to observe the distribution of TRPA1,TRPV1 channels and the relationship between it and cough reflex sensitivity.
1）Recruit chronic cough patients and healthy volunteers and complete related examinations as mentioned before.
2)Collect mucosa specimens from upper trachea via endobronchial biopsy,and airway epithelial cells from 2nd or 3rd order bronchi via brushing.
3)Evaluate the expression level of TRPA1,TRPV1 of mucosa specimens of subjects by immunofluorescent assay and Image analysis software.
4)Cultivate airway epithelial cells from subjects and evaluate the expression of TRPV1,TRPA1 and functional changes of it.
1. Recruit chronic cough patients and healthy volunteers as subjects.
2. Help subjects to complete detailed history,physical examination,Hull airway reflux questionnaire,chest x-rays,induced sputum,blood routine test,pulmonary ventilation function test and histamine provocation test before they enter this study.
3. Complete allyl isothiocynate(AITC) cough provocation test the day subjects enter the study,then complete capsaicin（CAP）cough provocation test after 3 days.
4. To detect the substance P(SP),calcitonin gene-related peptide(CGRP),prostaglandin E2(PGE2),et al level in sputum supernatants.
Secondly,to observe the distribution of TRPA1,TRPV1 channels and the relationship between it and cough reflex sensitivity.
1）Recruit chronic cough patients and healthy volunteers and complete related examinations as mentioned before.
2)Collect mucosa specimens from upper trachea via endobronchial biopsy,and airway epithelial cells from 2nd or 3rd order bronchi via brushing.
3)Evaluate the expression level of TRPA1,TRPV1 of mucosa specimens of subjects by immunofluorescent assay and Image analysis software.
4)Cultivate airway epithelial cells from subjects and evaluate the expression of TRPV1,TRPA1 and functional changes of it.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: