Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Une… (NCT06600646) | Clinical Trial Compass
RecruitingNot Applicable
Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
Canada30 participantsStarted 2024-11-22
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.