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临床试验/NCT02591550
NCT02591550Unknown不适用

A Study on the Mechanism of Cough Hypersensitivity

Kefang Lai1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
TRPA1,TRPV1 channels expression level of chronic cough patients and its relationship with cough reflex sensitivity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control

入排标准

年龄范围
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic cough group:
  • cough lasting ≥ 8 weeks,characterized by irritating dry cough.
  • sensitive to fumes,dust,the odorous and cold air.
  • with normal chest x-rays. 4.17-70 years old.
  • 5.without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result.

排除标准

  • chronic cough group and healty controls group:
  • with respiratory tract infection within 8 weeks.
  • with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease.
  • using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week.
  • women during pregnancy or lactation.
  • patients with malignant tumours.

结局指标

主要结局

TRPA1,TRPV1 channels expression level of chronic cough patients and its relationship with cough reflex sensitivity

时间窗: 7 days post-bronchoscopy

Complete AITC cough provocation test the day subjects enter the study,then complete CAP cough provocation test after 3 days,record the threshold of cap and aitc concentration(mmol/L) when it cause subjects cough equal to or more than 5 times.Measure the expression level of TRPA1 and TRPV1 of biopsy sample from chronic cough patients and healthy controls by immunofluoresent assay 7 days post bronchoscopy.Analyze the statistic by spss18.0.

次要结局

  • The relationship between CAP cough reflex sensitivity test conducted by TRPV1 and AITC cough reflex sensitivity test conducted by TRPA1(7 days post-bronchoscopy)

研究者

发起方
Kefang Lai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kefang Lai

Professor

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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