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Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00858624
Enrollment
24
Registered
2009-03-10
Start date
2008-02-29
Completion date
2009-07-31
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Cough

Keywords

Cough, Cough reflex, NMDA receptor, central sensitisation

Brief summary

A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult non-smoking population. Chronic cough has many associated complications including incontinence, muscular chest pains, blackouts and depression. Current treatment is often ineffective in these patients. To develop new medications the investigators need to understand more about the mechanisms that can lead to excessive coughing. This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic cough. The investigators hypothesise that that chronic cough patients have a more sensitive cough reflex as a result central nervous system hyper-excitability (central sensitisation). The investigators will measure cough reflex sensitivity before and after administration of ketamine, a medication that blocks an important receptor in the central nervous system.

Interventions

DRUGketamine

Administration of low dose intravenous ketamine. Dose: 0.075mg/kg over 10 minutes followed by 0.005mg/kg/min over 20 minutes. Given as single infusion.

Sponsors

Jacky Smith
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Volunteers: * Over 18 years old * Measurable cough reflex sensitivity * No current or past history of chronic cough or chronic respiratory disease. * No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip. Chronic Cough Patients * Over 18 years old * Chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease. * Normal CXR * Normal lung function * Measurable cough reflex sensitivity

Exclusion criteria

* Recent Upper Respiratory Tract Infection (4 weeks) * Pregnancy/breast feeding * Current smokers or ex-smokers with \< 6 months abstinence or cumulative history of \> 10 packyears * Diabetes Mellitus * Opiate or ACE Inhibitor use. * Any centrally acting medication which has the potential to alter cough reflex sensitivity. * Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness. * Drug or alcohol abuse * History of allergy or reaction to ketamine of other NMDA receptor antagonists.

Design outcomes

Primary

MeasureTime frame
Cough Reflex Sensitivity6 months

Secondary

MeasureTime frame
Upper Oesophageal Pain Thresholds6 months
Pain Thresholds Pharynx6 months
Pain Thresholds Chest Wall6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026