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An Investigation Into the Mechanism of Inhalation Cough Challenge

NCT02039999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-15

No results posted yet for this study

Summary

Despite its commonplace use in respiratory medicine the mechanism whereby inhalation challenge with a variety of mild acid aerosols produces a dose related and predictable cough is unknown. In this proposal the investigators wish to use established cough challenge methodology to explore the mechanism of action of agents provoking cough both in health and disease.

The hypotheses to be tested include:

* Intracellular changes in pH, rather than extracellular changes, are key in the activation of TRP receptors, the main sensor for provoking cough.
* ATP acting through P2X channels is the mechanism of increased nerve excitability underlying cough hypersensitivity.

Conditions

Interventions

OTHER

Nebulised citric acid in serial dilutions

Citric acid will be delivered in serial dilutions as per the clinical trials unit standard operating procedure for cough challenge using KoKo Digidoser, based on ERS guidelines. Challenge will be repeated until C5 (5 coughs in 30 seconds following challenge) is elicited.

OTHER

Nebulised ATP solution in serial dilutions

ATP solution will be delivered in serial dilutions as per the clinical trials unit standard operating procedure for cough challenge using KoKo Digidoser, based on ERS guidelines. Challenge will be repeated until C5 (5 coughs in 30 seconds following challenge) is elicited.

OTHER

Nebulised TRPA1 agonist solution in serial dilutions

TRPA1 agonist will be delivered in serial dilutions as per the clinical trials unit standard operating procedure for cough challenge using KoKo Digidoser, based on ERS guidelines. Challenge will be repeated until C5 (5 coughs in 30 seconds following challenge) is elicited.

Sponsors & Collaborators

  • Hull University Teaching Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Alyn H Morice, MD, FRCP · National Health Service, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2016-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039999 on ClinicalTrials.gov