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

NCT ID: NCT06600646

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Chronic Cough (CC)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Refractory or Unexplained Chronic Cough

Bronchoscopy

Intervention Type: DIAGNOSTIC_TEST

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

Healthy Controls

Bronchoscopy

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Bronchoscopy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imran Satia, MB BChir (cantab) MRCP PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Imran Satia

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Imran Satia, MB BChir (cantab) MRCP PhD

Role: CONTACT

satiai@mcmaster.ca

905-521-2100 ext. 76645

Facility Contacts

Imran Satia, MD PhD

Role: primary

satiai@mcmaster.ca

Other Identifiers

Hireb:17668

Identifier Type: -

Identifier Source: org_study_id