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OpenTrials
Completed

NCT Number: NCT00858624

Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manchester, Education and Research Centre, Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Cough Reflex Sensitivity

    Time frame: 6 months

Secondary outcomes

  1. Upper Oesophageal Pain Thresholds

    Time frame: 6 months

  2. Pain Thresholds Pharynx

    Time frame: 6 months

  3. Pain Thresholds Chest Wall

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Jacky Smith

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2009
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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