A Study on the Mechanism of Cough Hypersensitivity

NCT ID: NCT02591550

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cough

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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patients with normal cough sensitivity

No interventions assigned to this group

patients with high cough sensitivity

No interventions assigned to this group

healty controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

chronic cough group:

1. cough lasting ≥ 8 weeks,characterized by irritating dry cough.
2. sensitive to fumes,dust,the odorous and cold air.
3. 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.

Exclusion Criteria

chronic cough group and healty controls group:

1. with respiratory tract infection within 8 weeks.
2. with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease.
3. using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week.
4. women during pregnancy or lactation.
5. patients with malignant tumours.
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kefang Lai

OTHER

Sponsor Role lead

Responsible Party

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Kefang Lai

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kefang Lai, PhD

Role: CONTACT

8620-83062893

Facility Contacts

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Kefang Lai, PhD

Role: primary

8620-83062893

References

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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.

Reference Type DERIVED
PMID: 31552721 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31170994 (View on PubMed)

Other Identifiers

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coughlongli

Identifier Type: -

Identifier Source: org_study_id

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