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Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity

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

Tracking Information
First Submitted Date  ICMJE March 9, 2009
First Posted Date  ICMJE March 10, 2009
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
Cough Reflex Sensitivity [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Cough
Intervention  ICMJE 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  ICMJE
  • Active Comparator: Chronic Cough Patients
    Intervention: Drug: ketamine
  • Active Comparator: Healthy Volunteers
    Intervention: Drug: ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00858624
Other Study ID Numbers  ICMJE 07/H1004/142
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacky Smith, University of Manchester
Study Sponsor  ICMJE Jacky Smith
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Manchester
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP