Menu
Recruiting NCT06600646

Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).

— Observational Chronic Cough (CC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bronchoscopy.
Who it may be relevant to
Registry conditions: Chronic Cough (CC). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Chronic cough is a common troublesome symptom which has a global prevalence of approximately 10%, but with wide variations across continents. Patients with refractory and unexplained chronic cough (RCC/UCC) often exhibit dysregulated vagal pathways, necessitating a neuronal biomarker for targeted treatment. ATP, involved in the ATP/P2X3 pathway, may serve as a potential biomarker due to its role in the cough reflex. The study aims to discover if ATP production by the airway epithelium is greater in RCC/UCC patients compared with healthy controls, if the epithelium is a source of ATP, whether gene and protein expression related to ATP production differs between these groups and whether ATP release is triggered by mechanical and chemical stimulation. Additionally, the study seeks to determine if biomarker gene expression signatures can differentiate RCC/UCC patients from healthy controls.

Interventions

  • Diagnostic test Bronchoscopy
    Bronchoscopy will be performed in patients with refractory or unexplained chronic cough and healthy controls.

Primary outcome measures

  • Difference in expressed genes [Time frame: At baseline]
Secondary outcome measures (4)
  • Difference Immune Cells and Cytokines [Time frame: 12 months]
  • Gene Expression [Time frame: At baseline]
  • Difference in Nerve Morphology [Time frame: baseline]
  • Difference in ATP release [Time frame: 5,15,30 minutes]

Eligibility criteria

Inclusion Criteria for RCC/UCC:

  • Patients with a history of RCC/UCC.
  • Normal Chest X-ray in the last 5 years.
  • No Evidence of Airflow Obstruction (FEV1/FVC ratio above LLN)
  • Cough Severity VAS ≥ 40 mm at screening.

Inclusion Criteria for Healthy Controls:

  • No history of chronic cough, asthma, COPD, or clinical history of bronchiectasis or interstitial lung disease
  • No current smokers or those with \>10 pack year history.
  • No evidence of airflow obstruction ( FEV1/FVC ratio above LLN).
  • Able to understand and give written informed consent.

Exclusion criteria

  • Participants who are currently established on treatment and their chronic cough is well controlled.
  • Unable to perform acceptable and reproducible spirometry.
  • Participants with a positive covid-19 test within 2 weeks of screening.
  • Current smoker or ex-smoker with ≥20 pack year smoking history and abstinence of ≤6 months
  • Symptoms of upper respiratory tract infection in the last 1 month which have not resolved
  • Lower respiratory tract infection or pneumonia in the last 1 month
  • Asthma exacerbation in the previous month requiring an increase or start of an inhaled corticosteroid (ICS) or oral corticosteroid (OCS)
  • Significant other primary pulmonary disorders in particular; pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, significant radiologically proven emphysema, interstitial lung disease or bronchiectasis.
  • History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
  • Allergy or intolerance to sedation medication including fentanyl and midazolam, or a history of complications during procedural sedation
  • Severe coagulopathy, bleeding disorder, or medical need for anti- coagulation that would increase the risk of endobronchial biopsy as determined by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Canada · 1 center
  • Imran Satia — Hamilton

Identifiers

NCT: NCT06600646 · Hireb:17668

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗