Back to resultsNeurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Primary Purpose
Chronic Cough
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ketamine
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Cough focused on measuring Cough, Cough reflex, NMDA receptor, central sensitisation
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.
Sites / Locations
- University of Manchester, Education and Research Centre, Wythenshawe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Chronic Cough Patients
Healthy Volunteers
Arm Description
Outcomes
Primary Outcome Measures
Cough Reflex Sensitivity
Secondary Outcome Measures
Upper Oesophageal Pain Thresholds
Pain Thresholds Pharynx
Pain Thresholds Chest Wall
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00858624
Brief Title
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Official Title
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacky Smith
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
Cough, Cough reflex, NMDA receptor, central sensitisation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronic Cough Patients
Arm Type
Active Comparator
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
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 Outcome Measure Information:
Title
Cough Reflex Sensitivity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Upper Oesophageal Pain Thresholds
Time Frame
6 months
Title
Pain Thresholds Pharynx
Time Frame
6 months
Title
Pain Thresholds Chest Wall
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Manchester, Education and Research Centre, Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
We'll reach out to this number within 24 hrs