Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients

NCT06286163 | Recruiting DMC

• 1 other identifier: PA4099
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done in order to understand what causes people to have a chronic cough, which is defined as a cough lasting for more than 8 weeks. The research team wish to find out whether there is any inflammation in the lungs of patients with chronic cough. The research team will also determine whether a suspected chemical produced in the body, called adenosine triphosphate (ATP) can be responsible for causing the chronic cough. In order to be able to find out what is abnormal in those who have a chronic cough, The research team will need to compare their results with those that do not have a chronic cough. In this study, the research team will examine 10 participants who suffer from chronic cough and 8 individuals who do not have a chronic cough and are healthy.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (3)

• Presence of ATP in airways of idiopathic chronic cough patients and the localisation of P2X2/3 receptors in the airways

  Measure ATP concentrations in exhaled breath condensate and use immunohistochemistry to identify P2X2/3 receptors in lung endobronchial biopsies.

  18 months

• Cough sensitivity and laryngeal sensitivity to exogenous ATP

  Count the number of cough in response to capsaicin pre and post ATP exposure

  18 months

• Examine the effects of exogenous ATP on the inflammatory response in the upper and lower airways.

  Count the number of immune cells in sputum and BALF pre and post ATP by microscopy

  18 months

Study Arms (2)

Chronic Cough

History of chronic cough of at least 8 weeks' duration and should have been followed in the Cough Clinic for at least 6 months. Undergone a protocol with a diagnostic pathway as recommended by the ERS guidelines for management of cough. Would have either an identifiable cause for their cough that have failed therapies targeted towards the identified cause or classed as having chronic idiopathic cough where no identifiable cause has been found.

Healthy

Healthy individuals, free of significant disease No history of asthma/rhinitis, No therapies, Baseline FEV1 ≥80% predicted with FEV1/FVC ratio \>70% Non-smoker for at least the past 12 months with a pack history of ≤5 pack-years

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who suffer from chronic cough and healthy volunteers

You may qualify if:

• \- 1. For Normal non-smoking subject: Healthy individuals, free of significant disease No history of asthma/rhinitis, No therapies, Baseline FEV1 ≥80% predicted with FEV1/FVC ratio \>70% Non-smoker for at least the past 12 months with a pack history of ≤5 pack-years
• \. For chronic cough participants: History of chronic cough of at least 8 weeks' duration and should have been followed in the Cough Clinic for at least 6 months.
• Undergone a protocol with a diagnostic pathway as recommended by the ERS guidelines for management of cough.
• Would have either an identifiable cause for their cough that have failed therapies targeted towards the identified cause or classed as having chronic idiopathic cough where no identifiable cause has been found.
• Male or female subject aged between 30 and 70 years old at screening. Able to complete the study and all measurements. Able to read, comprehend, and write at a sufficient level to complete study related materials.

Sponsors & Collaborators

• Imperial College London: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Royal Brompton & Harefield NHS Trust,

London, SW3 6HP, United Kingdom

RECRUITING

Royal Brompton Hospital

London, SW3 6HP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kian Fan Chung, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kian Fan Chung, MD

CONTACT

442075947959; f.chung@imperial.ac.uk

Pankaj Bhavsar, PhD

CONTACT

442075947961; p.bhavsar@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: October 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)