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Clinical trial

ATP and P2X3 Receptor in Chronic Cough

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Last updated:5th Feb 2023
Status: Not yet recruiting
Identifier: NCT05713019
ATP and P2X3 Receptor in Chronic Cough

This is a laboratory-based study that will be performed at the Clinical Research Centre at the Royal Brompton Hospital,London. The objectives are:

1. Determine whether adenosine triphosphate (ATP) is present or released in airways of idiopathic chronic cough patients
2. Determine whether there is an increase in cough sensitivity and laryngeal sensitivity to exogenous ATP
3. Examine the effects of exogenous ATP on the inflammatory response in the upper and lower airways.

The participants will be: (i) Healthy subjects: non-smoker (8 subjects) and (ii) Chronic cough subjects attending Chronic Cough clinic (12 subjects). Each will be involved in:

Study 1. Following recruitment, subjects will attend for a fiberoptic bronchoscopy.

Study 2: Subjects will take part in a study of the effect of inhaling nebulized ATP. Subjects will be studied on 2 days separated by at least 5 days. On each day, after measurements of lung function, FeNO and cough questionnaires, the subject will inhale either saline or ATP solution from a nebulizer, following which laryngeal hypersensitivity, capsaicin cough challenge and sputum induction will be performed.

Results will be expressed as mean ± standard error of the mean (SEM). Study data will be analysed by the Investigators at the completion of the study. Planned analyses will be done by comparing chronic cough patients to the healthy controls. The Spearman rank-correlation test will be used to determine correlations.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Compare effect of diluent with ATP.
Masking: Double (Participant, Investigator)
Masking Description: Participant and Investigator will be blinded as to whether saline or ATP is being given.
Primary Purpose: Diagnostic
Official Title: Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients: an Exploratory Study
Estimated Study Start Date: February 28, 2023
Estimated Primary Completion Date: March 28, 2024
Estimated Study Completion Date: August 31, 2024

- Placebo Comparator: Effect of saline
- Active Comparator: Effect of ATP

Category Value
Study type(s) Interventional
Estimated enrolment 20
Estimated Study start date 28 February 2023
Estimated Study Completion Date 31 August 2024

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