ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis

NCT ID: NCT03638063

Last Updated: 2020-02-11

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-29

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Cough Bronchiectasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic cough

patients with chronic cough who remain clinically stable

Adenosine Triphosphate

Intervention Type DIAGNOSTIC_TEST

Adenosine Triphosphate aerosol

capsaicin

Intervention Type DIAGNOSTIC_TEST

capsaicin aerosol

Bx

bronchiectasis patients who remain clinically stable

Adenosine Triphosphate

Intervention Type DIAGNOSTIC_TEST

Adenosine Triphosphate aerosol

capsaicin

Intervention Type DIAGNOSTIC_TEST

capsaicin aerosol

Control

healthy controls

Adenosine Triphosphate

Intervention Type DIAGNOSTIC_TEST

Adenosine Triphosphate aerosol

capsaicin

Intervention Type DIAGNOSTIC_TEST

capsaicin aerosol

Interventions

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Adenosine Triphosphate

Adenosine Triphosphate aerosol

Intervention Type DIAGNOSTIC_TEST

capsaicin

capsaicin aerosol

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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Weijie Guan

Associated professor; principal investigator (respiratory medicine)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-fang Lai, MD

Role: STUDY_CHAIR

Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical

Locations

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First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei-jie Guan, MD

Role: CONTACT

+86-13826042052

Jing jing Yuan, Msc

Role: CONTACT

+86-13502414649

Facility Contacts

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Wei-jie Guan

Role: primary

Ke-fang Lai

Role: backup

References

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Fowles HE, Rowland T, Wright C, Morice A. Tussive challenge with ATP and AMP: does it reveal cough hypersensitivity? Eur Respir J. 2017 Feb 8;49(2):1601452. doi: 10.1183/13993003.01452-2016. Print 2017 Feb.

Reference Type BACKGROUND
PMID: 28179439 (View on PubMed)

Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Capsaicin cough sensitivity and the association with clinical parameters in bronchiectasis. PLoS One. 2014 Nov 19;9(11):e113057. doi: 10.1371/journal.pone.0113057. eCollection 2014.

Reference Type BACKGROUND
PMID: 25409316 (View on PubMed)

Torrego A, Haque RA, Nguyen LT, Hew M, Carr DH, Wilson R, Chung KF. Capsaicin cough sensitivity in bronchiectasis. Thorax. 2006 Aug;61(8):706-9. doi: 10.1136/thx.2005.049767. Epub 2006 Apr 6.

Reference Type BACKGROUND
PMID: 16601085 (View on PubMed)

Fuller RW. Cough provocation tests: their clinical value. Pulm Pharmacol Ther. 2002;15(3):273-6. doi: 10.1006/pupt.2002.0355.

Reference Type BACKGROUND
PMID: 12099777 (View on PubMed)

Other Identifiers

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GuangzhouIRD01

Identifier Type: -

Identifier Source: org_study_id

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