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临床试验/NCT03638063
NCT03638063Unknown不适用

Adenosine Triphosphate and Capsaicin Cough Provocation Test for Identifing Patients With Chronic Cough Who Have Differential Responses to Purinergic Receptor Antagonists: a Randomized, Cross-over, Single-blind Trial

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月29日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
C5 (Provocant concentration eliciting at least 5 coughs)

研究概览

简要总结

This is a randomized, cross-over, single-blind trial. Eligible patients will be randomly assigned to undergo either capsaicin or adenosine triphosphate (ATP) cough provocation test, followed by a washout period of 2 to 14 days. Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for ~2 hours following the cough provocation tests in case of severe adverse events.

详细描述

This is a randomized, cross-over, single-blind trial. After verification of the entry criteria, eligible patients will be, based on the randomization codes, randomly assigned to undergo either capsaicin or ATP cough provocation test (the participants will inhale capasaicin or ATP incremental concentration to induce cough, meanwhile the number of coughs and adverse events will be recorded in each concentration during the first 30 seconds), followed by a washout period of 2 to 14 days (no major changes in the use of concomitant medications are allowed,especially the medcines which are not allowed before test ). Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for ~2 hours following the cough provocation tests in case of severe adverse events. Twenty four hours after each test, a follow-up telephone visit will be scheduled for all patients to record any response which may be related to the test.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Out-patients of either gender, ex- or never-smokers, aged between 18 and 60 years
  • •Cough symptoms lasting for more than 8 weeks
  • •Remaining free of acute upper respiratory tract infection for at least 4 weeks
  • •Agreed to participate in the trial and signed informed consent.

排除标准

  • •Patients with serious systemic diseases (such as malignant tumors), bullae, severe uncontrolled asthma, and a history of major hemoptysis
  • •Systemic antibiotic use (except for maintenance low-dose macrolides) within 4 weeks
  • •Pregnancy or lactation
  • •Any known history of sensitivity to ATP or capsaicin
  • •Poor understanding of the test procedure
  • •Diagnosed with cough variant asthma or Eosinophilic bronchitis

结局指标

主要结局

C5 (Provocant concentration eliciting at least 5 coughs)

时间窗: 18 months

Provocant concentration eliciting at least 5 coughs

次要结局

  • ED50 (half maximal effective Dose)(18 months)
  • Emax (effective concentration of provocant eliciting maximal cough count)(18 months)
  • potency ratio(18 months)
  • Difference in cough VAS score (a 10-point likert scale for assessing the global severity of cough, no subscale was applied)(18 months)
  • The incidence of adverse events (i.e. dry throat , pharyngeal itching)(18 months)
  • Cough dose ratio (CDR)(18 months)

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weijie Guan

Associated professor; principal investigator (respiratory medicine)

Guangzhou Institute of Respiratory Disease

研究点 (1)

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