Status:
COMPLETED
Neurophysiology of Cough Reflex Hypersensitivity
Lead Sponsor:
University of Manchester
Collaborating Sponsors:
JP Moulton Charitable Foundation
Medical Research Council
Conditions:
Cough
Healthy Controls
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chro...
Eligibility Criteria
Inclusion
- Healthy volunteers inclusion:
- Over 18 years
- Measurable cough reflex sensitivity - required as is the primary end-point
- No current or past history of chronic cough or chronic respiratory disease
- Chronic Cough Patients inclusion:
- Over 18 years
- Chronic persistent cough (\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux
- Normal chest radiograph - primary respiratory cause for cough excluded
- Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point
Exclusion
- Recent upper respiratory tract infection (\<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles
- Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion
- Current smokers or ex-smokers with \< 6 month abstinence or history \> 20 pack years - smoking can alter the sensitivity of the cough reflex
- Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity
- Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity
- Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00977366
Start Date
March 1 2010
End Date
February 1 2013
Last Update
June 19 2013
Active Locations (1)
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1
University Hospital of South Manchester
Manchester, United Kingdom, M23 9LT