ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis

February 8, 2020 updated by: Weijie Guan, Guangzhou Institute of Respiratory Disease

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with chronic cough (including bronchiectasis) who remained clinically stable for at least 4 weeks

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic cough
patients with chronic cough who remain clinically stable
Diagnostic test: Adenosine Triphosphate
Adenosine Triphosphate aerosol
Diagnostic test: capsaicin
capsaicin aerosol
Bx
bronchiectasis patients who remain clinically stable
Diagnostic test: Adenosine Triphosphate
Adenosine Triphosphate aerosol
Diagnostic test: capsaicin
capsaicin aerosol
Control
healthy controls
Diagnostic test: Adenosine Triphosphate
Adenosine Triphosphate aerosol
Diagnostic test: capsaicin
capsaicin aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C5 (Provocant concentration eliciting at least 5 coughs)
Time Frame: 18 months
Provocant concentration eliciting at least 5 coughs
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED50 (half maximal effective Dose)
Time Frame: 18 months
50% effective dose of provocant
18 months
Emax (effective concentration of provocant eliciting maximal cough count)
Time Frame: 18 months
effective concentration of provocant eliciting maximal cough count
18 months
potency ratio
Time Frame: 18 months
ATP/capsaicin 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)
Time Frame: 18 months
The difference between pre- and post-challenge cough VAS scores
18 months
The incidence of adverse events (i.e. dry throat , pharyngeal itching)
Time Frame: 18 months
adverse events such as dry throat , pharyngeal itching, wheeze or dyspnea according to the subject's reporting to record the rate of the incidence and the severity (the aboved-mentioned VAS score would be applied)
18 months
Cough dose ratio (CDR)
Time Frame: 18 months
the ratio of cough count and dose/concentration
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Investigators

  • Study Chair: Ke-fang Lai, MD, Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 8, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangzhouIRD01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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