Chronic Cough and Small Fiber Neuropathy (NCT03787511) | Clinical Trial Compass
TerminatedNot Applicable
Chronic Cough and Small Fiber Neuropathy
Stopped: patients difficult to recruit
France7 participantsStarted 2022-06-14
Plain-language summary
Diabetic patients with and without chronic cough will be included in this study. After giving their informed consent, the patients will perform a spirometry, chest X-ray at the inclusion visit. Cough will be assessed using the cough visual analog scale (VAS) and the Leicester Cough Questionnaire (LCQ). Within 60 days, the patient will perform neurophysiological tests. The neurophysiological assessment will be concluded with a skin biopsy to evaluate small fiber neuropathy. The aim of the study is to compare the proportion of small fiber neuropathy between diabetic patients with chronic cough and those without 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:
In diabetic patients with chronic cough:
* Chronic cough defined by cough for more than 8 weeks.
* Normal chest X-ray
* history of type 2 diabetes
* Age of diabetes onset\> 40 years
* Affiliated or beneficiary person of social security
* Free, informed and written consent
In diabetic patients without chronic cough
* History of type 2 diabetes
* Age of discovery of diabetes\> 40 years
* Affiliated or beneficiary person of social security
* Free, informed and written consent
Exclusion Criteria:
* Presence of physical signs of peripheral neuropathy
* Active smoking or smoking cessation within the last 12 months
* Pregnant or lactating woman
* History of non-type 2 diabetes (type I, secondary diabetes, monogenic ...)
* Cancer within the last 5 years (except cutaneous squamous cell carcinoma)
* History of anti-cancer chemotherapy
* Suspicion of autoimmune pathology
* Active neurological pathology
* Electromyography in favor of large fiber neuropathy
* Chronic pathology that may interfere with the neurophysiological assessment
* Patient who were given anticoagulation drug therapy, anti-cholinergic drugs, beta-blocker and impossibility to withdraw the treatment before neurophysiological tests
In diabetic patients without chronic cough, another non-inclusion criteria is acute or chronic cough
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
Proportion of patients with small fiber neuropathy