Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

NCT00858624 | Completed

• 1 other identifier: 07/H1004/142
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough

Keywords

Cough; Cough reflex; NMDA receptor; central sensitisation

Outcome Measures

Primary Outcomes (1)

• Cough Reflex Sensitivity

  6 months

Secondary Outcomes (3)

• Upper Oesophageal Pain Thresholds

  6 months

• Pain Thresholds Pharynx

  6 months

• Pain Thresholds Chest Wall

  6 months

Study Arms (2)

Chronic Cough Patients

ACTIVE COMPARATOR

Drug: ketamine

Healthy Volunteers

ACTIVE COMPARATOR

Drug: ketamine

Interventions

ketamine DRUG

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.

Chronic Cough Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jacky Smith: lead

Study Sites (1)

University of Manchester, Education and Research Centre, Wythenshawe Hospital

Manchester, Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Chronic Cough; Cough

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Reader

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

GB (1)