Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

• ClinicalTrials.gov Identifier: NCT00858624
• Recruitment Status: Completed
• First Posted: March 10, 2009
• Last Update Posted: June 19, 2013
• Sponsor: Jacky Smith
• Information provided by (Responsible Party): Jacky Smith, University of Manchester

Tracking Information

• First Submitted Date: March 9, 2009
• First Posted Date: March 10, 2009
• Last Update Posted Date: June 19, 2013
• Study Start Date: February 2008
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 9, 2009): Cough Reflex Sensitivity [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 9, 2009)

• Upper Oesophageal Pain Thresholds [ Time Frame: 6 months ]
• Pain Thresholds Pharynx [ Time Frame: 6 months ]
• Pain Thresholds Chest Wall [ Time Frame: 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
• Official Title: Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Health Services Research
• Condition: Chronic Cough

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.

Study Arms

• Active Comparator: Chronic Cough Patients
  Intervention: Drug: ketamine
• Active Comparator: Healthy Volunteers
  Intervention: Drug: ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2009): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00858624
• Other Study ID Numbers: 07/H1004/142
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jacky Smith, University of Manchester
• Original Responsible Party: Dr J A Smith, University of Manchester
• Current Study Sponsor: Jacky Smith
• Original Study Sponsor: University of Manchester
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Manchester
• Verification Date: June 2013