Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 65 of 1197 for:    Adenosine

ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03638063
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Weijie Guan, Guangzhou Institute of Respiratory Disease

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Cough Bronchiectasis Diagnostic Test: Adenosine Triphosphate Diagnostic Test: capsaicin

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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




Primary Outcome Measures :
  1. C5 (Provocant concentration eliciting at least 5 coughs) [ Time Frame: 18 months ]
    Provocant concentration eliciting at least 5 coughs


Secondary Outcome Measures :
  1. ED50 (half maximal effective Dose) [ Time Frame: 18 months ]
    50% effective dose of provocant

  2. Emax (effective concentration of provocant eliciting maximal cough count) [ Time Frame: 18 months ]
    effective concentration of provocant eliciting maximal cough count

  3. potency ratio [ Time Frame: 18 months ]
    ATP/capsaicin potency ratio

  4. 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

  5. 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)

  6. Cough dose ratio (CDR) [ Time Frame: 18 months ]
    the ratio of cough count and dose/concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic cough (including bronchiectasis) who remained clinically stable for at least 4 weeks
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638063


Contacts
Layout table for location contacts
Contact: Wei-jie Guan, MD +86-13826042052 battery203@163.com
Contact: Jing jing Yuan, Msc +86-13502414649 jacyyjj@163.com

Locations
Layout table for location information
China, Guangdong
First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Wei-jie Guan       battery203@163.com   
Contact: Ke-fang Lai       klai@163.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
Layout table for investigator information
Study Chair: Ke-fang Lai, MD Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical

Publications:
Layout table for additonal information
Responsible Party: Weijie Guan, Associated professor; principal investigator (respiratory medicine), Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT03638063     History of Changes
Other Study ID Numbers: GuangzhouIRD01
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weijie Guan, Guangzhou Institute of Respiratory Disease:
Adenosine triphosphate
Capsaicin
cough provocation test
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenosine
Cough
Bronchiectasis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Capsaicin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents