Status:
RECRUITING
Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
Lead Sponsor:
McMaster University
Conditions:
Chronic Cough (CC)
Eligibility:
All Genders
18-80 years
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 (RC...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06600646
Start Date
November 22 2024
End Date
December 31 2025
Last Update
May 8 2025
Active Locations (1)
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1
Imran Satia
Hamilton, Ontario, Canada, L8S 4L8