Trial record 20 of 772 for:
cough
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Manchester.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Manchester
Information provided by:
University of Manchester
ClinicalTrials.gov Identifier:
NCT00858624
First received: March 9, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Cough |
Drug: ketamine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
| Official Title: | Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity |
Resource links provided by NLM:
Further study details as provided by University of Manchester:
Primary Outcome Measures:
- Cough Reflex Sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Upper Oesophageal Pain Thresholds [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pain Thresholds Pharynx [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pain Thresholds Chest Wall [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Chronic Cough Patients |
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.
|
| Active Comparator: Healthy Volunteers |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858624
Contacts
| Contact: Jacky A Smith, MBChB, PhD | 0161 291 5879 | jacky.smith@manchester.ac.uk |
Locations
| United Kingdom | |
| University of Manchester, Education and Research Centre, Wythenshawe Hospital | Recruiting |
| Manchester, United Kingdom, M23 9LT | |
| Contact: Jacky A Smith, MBChB, PhD 0161 291 5879 jacky.smith@manchester.ac.uk | |
| Principal Investigator: Jacky A Smith, MBChB, PhD | |
Sponsors and Collaborators
University of Manchester
More Information
No publications provided
| Responsible Party: | Dr J A Smith, University of Manchester |
| ClinicalTrials.gov Identifier: | NCT00858624 History of Changes |
| Other Study ID Numbers: | 07/H1004/142 |
| Study First Received: | March 9, 2009 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by University of Manchester:
|
Cough Cough reflex NMDA receptor central sensitisation |
Additional relevant MeSH terms:
|
Cough Hypersensitivity Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Immune System Diseases Ketamine Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013