Investigating ATP production in patients with chronic cough

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

This study is testing if the way the lungs produce ATP, a type of energy, is different in people with chronic cough compared to healthy individuals, to see if it can help guide better treatments.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT06600646 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with refractory and unexplained chronic cough (RCC/UCC) to explore the role of ATP production by the airway epithelium. It aims to compare ATP levels and gene expression related to ATP production between RCC/UCC patients and healthy controls. The study will utilize bronchoscopy to assess ATP production and its potential as a biomarker for targeted treatment. Additionally, it seeks to determine if mechanical and chemical stimulation affects ATP release in these patients.

Who should consider this trial

Good fit: Ideal candidates include individuals with a history of refractory and unexplained chronic cough who meet specific inclusion criteria.

Not a fit: Patients whose chronic cough is well controlled or who have significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new biomarkers for diagnosing and treating chronic cough.

How similar studies have performed: While the role of ATP in cough reflex is being explored, this specific approach appears to be novel and untested.

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

Where this trial is running

Hamilton, Ontario

• Imran Satia — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Imran Satia, MB BChir (cantab) MRCP PhD — McMaster University
• Study coordinator: Imran Satia, MB BChir (cantab) MRCP PhD

Conditions Chronic Cough; chronic cough; ATP; airway nerves