Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

Chronic Cough Clinical Trial

Official title:

Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858624
• Other study ID #: 07/H1004/142
• Status: Completed
• Phase: N/A
• First received: March 9, 2009
• Last updated: June 17, 2013
• Start date: February 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2013
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Cough
• Cough
• Hypersensitivity

Intervention

Drug:
• ketamine
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.

Locations

Country	Name	City	State
United Kingdom	University of Manchester, Education and Research Centre, Wythenshawe Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Jacky Smith

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough Reflex Sensitivity		6 months	No
Secondary	Upper Oesophageal Pain Thresholds		6 months	No
Secondary	Pain Thresholds Pharynx		6 months	No
Secondary	Pain Thresholds Chest Wall		6 months	No