Neurophysiology of Cough Reflex Hypersensitivity (NCT00977366) | Clinical Trial Compass
CompletedNot Applicable
Neurophysiology of Cough Reflex Hypersensitivity
United Kingdom27 participantsStarted 2010-03
Plain-language 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 chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.
The main questions in this study include:
1. Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?
2. Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?
In animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
* 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 illnes…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of oesophageal acid infusion on cough reflex sensitivity in chronic cough patients compared to healthy controls.
Timeframe: baseline, immediatley after infusion, 90 minutes post infusion, 180 minutes post infusion, 24 hours after baseline