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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of ATP production by the airway epithelium in patients with refractory and unexplained chronic cough (RCC/UCC), a condition affecting about 10% of people globally with varying severity. The study aims to find if the airway epithelium produces more ATP in RCC/UCC patients compared to healthy individuals and whether gene and protein expressions linked to ATP production differ between these groups. It also explores if ATP release is triggered by mechanical or chemical stimulation and if gene expression patterns can distinguish RCC/UCC patients from healthy controls. The study involves performing bronchoscopy, a diagnostic test, on both RCC/UCC patients and healthy controls to collect airway samples for analysis. This observational study compares gene expression, immune cell levels, cytokines, nerve morphology, and ATP release over time between these two groups. The primary outcome is the difference in expressed genes at baseline, with secondary outcomes including changes in immune cells and cytokines at 12 months and ATP release at several time points. Participants will undergo assessments including spirometry to measure lung function and bronchoscopy to collect samples. Researchers will analyze gene expression, nerve structure, and immune responses. The study tracks cough severity and airflow measures at screening and monitors participants for up to 12 months to observe changes. Safety evaluations include screening for recent infections and smoking history. The total involvement duration varies but includes baseline and follow-up assessments to understand the biological differences associated with chronic cough.
CONDITIONS
Brief 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 past 5 years
- No evidence of airflow obstruction with FEV1/FVC ratio above lower limit of normal
- Cough severity of 40 mm or higher on a visual analogue scale 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 years smoking history
- Healthy controls with no evidence of airflow obstruction
- Able to understand and provide written informed consent
You will not qualify if you...
- Currently well-controlled chronic cough on treatment
- Unable to perform acceptable and reproducible spirometry
- Positive COVID-19 test within 2 weeks of screening
- Current smoker or ex-smoker with 20 or more pack years 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 an increase or start of corticosteroid treatment
- Other significant primary pulmonary disorders such as pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, severe emphysema, interstitial lung disease, or bronchiectasis
- History of psychiatric illness, drug or alcohol abuse interfering with study participation
- Allergy or intolerance to sedation medications including fentanyl or midazolam, or history of complications during procedural sedation
- Severe bleeding disorders or medical need for anticoagulation increasing risk of biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo bronchoscopy to assess airway epithelium and collect diagnostic information.
1 visit (in-person)
Duration - 12 months
Participants are observed over time to assess immune cells, cytokines, gene expression, nerve morphology, and ATP release.
Follow-up visits as scheduled over 12 months
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
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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