Actively Recruiting
Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
Led by McMaster University · Updated on 2025-05-08
30
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a history of refractory or unexplained chronic cough
- Normal chest X-ray within the last 5 years
- No airflow obstruction (FEV1/FVC ratio above lower limit of normal)
- Cough severity visual analogue scale 40 mm or higher at screening
- Healthy controls with no history of chronic cough, asthma, COPD, bronchiectasis, or interstitial lung disease
- Healthy controls who are non-smokers or have less than or equal to 10 pack year smoking history
- Healthy controls with no airflow obstruction (FEV1/FVC ratio above lower limit of normal)
- Able to understand and give written informed consent
You will not qualify if you...
- Participants with chronic cough well controlled on current treatment
- Unable to perform acceptable and reproducible spirometry
- Positive COVID-19 test within 2 weeks of screening
- Current smokers or ex-smokers with 20 pack year or more smoking history and less than 6 months abstinence
- Symptoms of upper respiratory tract infection within the last month that have not resolved
- Lower respiratory tract infection or pneumonia within the last month
- Asthma exacerbation in the previous month requiring increased or new inhaled or oral corticosteroids
- Significant primary pulmonary disorders such as pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, emphysema, interstitial lung disease, or bronchiectasis
- History of psychiatric illness, drug or alcohol abuse affecting trial participation
- Allergy or intolerance to sedation medications including fentanyl and midazolam, or history of complications during procedural sedation
- Severe bleeding disorders or medical need for anticoagulation increasing risk during endobronchial biopsy as determined by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imran Satia
Hamilton, Ontario, Canada, L8S 4L8
Actively Recruiting
Research Team
I
Imran Satia, MB BChir (cantab) MRCP PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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