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ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis

G

Guangzhou Institute of Respiratory Disease

Status

Unknown

Conditions

Bronchiectasis
Chronic Cough

Treatments

Diagnostic Test: Adenosine Triphosphate
Diagnostic Test: capsaicin

Study type

Observational

Funder types

Other

Identifiers

NCT03638063
GuangzhouIRD01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Chronic cough
Description:
patients with chronic cough who remain clinically stable
Treatment:
Diagnostic Test: capsaicin
Diagnostic Test: Adenosine Triphosphate
Bx
Description:
bronchiectasis patients who remain clinically stable
Treatment:
Diagnostic Test: capsaicin
Diagnostic Test: Adenosine Triphosphate
Control
Description:
healthy controls
Treatment:
Diagnostic Test: capsaicin
Diagnostic Test: Adenosine Triphosphate

Trial contacts and locations

1

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Central trial contact

Jing jing Yuan, Msc; Wei-jie Guan, MD

Data sourced from clinicaltrials.gov

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