NCT02591550

Brief Summary

The aim of this study is described as follows,

  1. 1.To establish a validated method to test cough reflex sensitivity conducted by transient receptor potential vanilloid 1(TRPV1).
  2. 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. 3.To study the distribution of TRPA1 and TRPV1 channels and their relationship to cough reflex sensitivity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

October 21, 2015

Last Update Submit

October 28, 2015

Conditions

Keywords

chronic coughcough reflex sensitivitytransient receptor potential vanilloid 1transient receptor potential ankyrin 1

Outcome Measures

Primary Outcomes (1)

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

    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.

    7 days post-bronchoscopy

Secondary Outcomes (1)

  • The relationship between CAP cough reflex sensitivity test conducted by TRPV1 and AITC cough reflex sensitivity test conducted by TRPA1

    7 days post-bronchoscopy

Study Arms (3)

patients with normal cough sensitivity

patients with high cough sensitivity

healty controls

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic cough group:nonsmokers with chronic cough lasting ≥ 8 weeks characterized by irritating dry cough or small amount of sputum, sensitive to fumes,dust, cold air ,and normal chest x-ray were enrolled. Healthy control:healthy volunteers presented our hospital for healthy examination were enrolled.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 520120, China

RECRUITING

Related Publications (2)

  • Lai K, Long L, Yi F, Tang J, Chen Z, Chen F, Zhou J, Peng W, Zhang L, Li H, Zhan W, Chen R, Luo W, Chen Q, Chung KF, Zhong N. Age and Sex Distribution of Chinese Chronic Cough Patients and Their Relationship With Capsaicin Cough Sensitivity. Allergy Asthma Immunol Res. 2019 Nov;11(6):871-884. doi: 10.4168/aair.2019.11.6.871.

  • Long L, Yao H, Tian J, Luo W, Yu X, Yi F, Chen Q, Xie J, Zhong N, Chung KF, Lai K. Heterogeneity of cough hypersensitivity mediated by TRPV1 and TRPA1 in patients with chronic refractory cough. Respir Res. 2019 Jun 6;20(1):112. doi: 10.1186/s12931-019-1077-z.

Biospecimen

Retention: SAMPLES WITHOUT DNA

mucosa of upper trachea

MeSH Terms

Conditions

CoughChronic Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kefang Lai, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 29, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations