Chronic Cough (CC)APECNCT06600646
Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
An observational study of Chronic Cough (CC), run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cough (CC)
- What is being tested?
- Bronchoscopy
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 Nov 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls will be recruited through local advertising, existing study databases or participation in previous studies where they have given permission to be contacted. Participants with RCC/UCC will be recruited by the investigators from existing study databases, clinics at either of the following sites: McMaster University Medical Centre, Department of Respiratory Medicine, 1200 Main St. West, Hamilton, Ontario, Canada, L8N 3Z5 Firestone Institute for Respiratory Health, St Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON L8N 4A6
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Imran Satia
Hamilton, Ontario, L8S 4L8
Imran Satia, MD PhD, satiai@mcmaster.ca
About this study
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
- Chronic Cough (CC)
- Being tested
- Bronchoscopy
- Keywords
- chronic cough, ATP, airway nerves
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDiagnostic test
Bronchoscopy will be performed in patients with refractory or unexplained chronic cough and healthy controls.
| Study group | Role | What they receive |
|---|---|---|
| Refractory or Unexplained Chronic Cough | Not described Receives: Diagnostic Test: Bronchoscopy | |
| Healthy Controls | Not described Receives: Diagnostic Test: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in expressed genes
Expression of genes involved in intracellular ATP production, transport, extracellular metabolism in the airway epithelium will be compared in both RCC/UCC and healthy controls.
Measured: At baseline
Secondary outcomes (4)
Difference Immune Cells and Cytokines
Investigate differences in the levels of neuroinflammatory mediators and immune cells from the respiratory airways and distal alveoli.
Measured: 12 months
Gene Expression
To compare the differences in RCC/UCC and healthy control in gene expression profiling in bronchial biopsies (sub-epithelial dominant).
Measured: At baseline
Difference in Nerve Morphology
Investigate differences in nerve length, nerve branch points, nerves expressive P2X3 receptors on airway sensory nerves expressing P2X3 receptor in RCC/UCC compared with healthy controls.
Measured: baseline
Difference in ATP release
ATP release from the cultured bronchial epithelial cells (BEC) taken from RCC/UCC and healthy controls after exposure to dynamic mechanical stretch and environmental exposures (cigarette smoke and NO2).
Measured: 5,15,30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cough (CC)Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Satia, MB BChir (cantab) MRCP PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600646
- Sponsor's protocol ID
- Hireb:17668
- Acronym
- APEC
- Status last verified
- May 2025
- First submitted
- 12 Sep 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is an single visit of 15 patients with RCC/UCC compared with 15 Healthy Controls undergoing bronchoscopy at single centre in Hamilton, Ontario, Canada. Due to the small sample size individual level details will not be shared to protect confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Role of ATP Production by Airway Epithelium in Patients With Refractory and Unexplained Chronic Cough (RCC/UCC).
- ClinicalTrials.gov ID
- NCT06600646
- Acronym / sponsor ID
- APEC / Hireb:17668
- Conditions
- Chronic Cough (CC)
- Keywords
- chronic cough, ATP, airway nerves
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refractory or Unexplained Chronic Cough | – | Diagnostic Test: Bronchoscopy |
| Healthy Controls | – | Diagnostic Test: Bronchoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls will be recruited through local advertising, existing study databases or participation in previous studies where they have given permission to be contacted. Participants with RCC/UCC will be recruited by the investigators from existing study databases, clinics at either of the following sites: McMaster University Medical Centre, Department of Respiratory Medicine, 1200 Main St. West, Hamilton, Ontario, Canada, L8N 3Z5 Firestone Institute for Respiratory Health, St Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON L8N 4A6
Key inclusion criteria (8 listed)
- 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.
- No history of chronic cough, asthma, COPD, or clinical history of bronchiectasis or interstitial lung disease
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyBronchoscopy will be performed in patients with refractory or unexplained chronic cough and healthy controls. | Diagnostic test | Healthy Controls, Refractory or Unexplained Chronic Cough |
Primary outcome
Difference in expressed genes
Time frame: At baseline
Expression of genes involved in intracellular ATP production, transport, extracellular metabolism in the airway epithelium will be compared in both RCC/UCC and healthy controls.
4 secondary outcomes
Difference Immune Cells and Cytokines
Time frame: 12 months
Gene Expression
Time frame: At baseline
Difference in Nerve Morphology
Time frame: baseline
Difference in ATP release
Time frame: 5,15,30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No. This is an single visit of 15 patients with RCC/UCC compared with 15 Healthy Controls undergoing bronchoscopy at single centre in Hamilton, Ontario, Canada. Due to the small sample size individual level details will not be shared to protect confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imran Satia, MB BChir (cantab) MRCP PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Cough (CC), run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Satia, MB BChir (cantab) MRCP PhD (905-521-2100 ext. 76645, satiai@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in expressed genes (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.