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Chronic Cough and Small Fiber Neuropathy (CHROCOS)

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ClinicalTrials.gov Identifier: NCT03787511
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Cough Type 2 Diabetes Other: Cough assessment Other: Neurological tests and cardiovascular tests Other: Skin biopsy Not Applicable

Detailed Description:

Chronic cough is a very common entity that affects 9.6% people worldwide. Given the high number of patients with refractory cough, the concept of cough hypersensitivity syndrome (CHS) has emerged. In CHS, afferent sensory nerves may exhibit a modification of activation patterns with facilitation of encoding signals in response to irritating stimuli. Similar patterns with neuropathic pain have been described. Small fiber neuropathy has never been assessed in chronic cough. Interestingly, diabetic patients experienced cough more frequently than healthy subject. We hypothesized that small fiber neuropathy may explain chronic cough is more frequent in diabetic patients.

Within 60 days after inclusion, diabetic patients with and without chronic cough will perform neurophysiological tests such as electromyography, thermotest, QSART (Quantitative Sudomotor Axon Reflex Test and Sudoscan), cardio-vascular tests to study the autonomic nervous system. No risks are expecting with these non-invasive tests. A skin biopsy to evaluate small fiber neuropathy will also be performed.After the neurophysiological tests, a consultation will be scheduled at 6 months. A cough VAS and LCQ will be used to assess cough.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Chronic Cough and Small Fiber Neuropathy
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Dietary Fiber

Arm Intervention/treatment
Diabetic patients with chronic cough
Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
Other: Cough assessment
Cough assessment with cough visual analog scale (VAS), and Leicester Cough Questionnaire (LCQ) for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Other: Neurological tests and cardiovascular tests
Neurological tests : electromyography, thermotest, QSAR + cardiovascular test for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Other: Skin biopsy
Skin biopsy to evaluate small fiber neuropathy for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Diabetic patients without chronic cough
Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
Other: Cough assessment
Cough assessment with cough visual analog scale (VAS), and Leicester Cough Questionnaire (LCQ) for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Other: Neurological tests and cardiovascular tests
Neurological tests : electromyography, thermotest, QSAR + cardiovascular test for Diabetic patients with chronic cough and Diabetic patients without chronic cough

Other: Skin biopsy
Skin biopsy to evaluate small fiber neuropathy for Diabetic patients with chronic cough and Diabetic patients without chronic cough




Primary Outcome Measures :
  1. Proportion of patients with small fiber neuropathy [ Time Frame: 6 month after inclusion visit ]
    The primary endpoint is the proportion of patients with small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough (defined by at least 2 abnormal neurophysiological tests).


Secondary Outcome Measures :
  1. proportion of patients with abnormal results of the thermotest [ Time Frame: 6 month after inclusion visit ]
    estimate the proportion of patients with abnormal results of the thermotest in each arm (with and without chronic cough)

  2. proportion of patients with pathological results of the sudori-motor response [ Time Frame: 6 month after inclusion visit ]
    estimate the proportion of patients with pathological results of the sudori-motor response in each arm (with and without chronic cough)

  3. the proportion of patients with abnormal results of cardiovascular tests [ Time Frame: 6 month after inclusion visit ]
    estimate the proportion of patients with abnormal results of cardiovascular tests assessing the autonomic nervous system in in each arm (with and without chronic cough)

  4. proportion of patients with abnormal results of laser evoked potentials [ Time Frame: 6 month after inclusion visit ]
    estimate the proportion of patients with abnormal results of laser evoked potentials in each arm (with and without chronic cough)

  5. proportion of patients with abnormal findings of cutaneous biopsy [ Time Frame: 6 month after inclusion visit ]
    estimate the proportion of patients with abnormal findings of cutaneous biopsy in in each arm (with and without chronic cough)

  6. values of Leicester Cough Questionnaire (LCQ) in diabetic patients [ Time Frame: 6 month after inclusion visit ]
    estimate the values of Leicester Cough Questionnaire in diabetic patients with and without chronic cough. The Leicester Cough Questionnaire comprises 19 items and takes 5 to 10 minutes to complete. Each item assesses symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life.

  7. values of the DN4 questionnaire in diabetic patients [ Time Frame: 6 month after inclusion visit ]

    estimate the values of the DN4 questionnaire in diabetic patients with and without chronic cough.

    It allows to estimate the probability of neuropathic pain in a patient, through 4 questions divided into 10 check items. The practitioner questions or examines the patient and completes the questionnaire himself. He notes a response ("yes", "no") to each item. At the end of the questionnaire, he counts the answers and assigns the note 1 for each "yes", and the score 0 for each "no". The sum obtained gives the score of the patient, scored out of 10.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787511


Contacts
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Contact: Laurent Guilleminault, MD 05-67-77-18-50 ext 33 guilleminault.a@chu-toulouse.fr

Locations
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France
Hôpital Larrey Recruiting
Toulouse, France, 31059
Contact: Laurent Guilleminault, MD         
Principal Investigator: Laurent Guilleminault, MD         
Sub-Investigator: Alain Didier, PH         
Sub-Investigator: Marion Dupuis, MD         
Sub-Investigator: Danielle Brouiquieres, MD         
Sub-Investigator: Vincent Fabry, MD         
Sub-Investigator: Anne Pavy-Le Traon, PH         
Sub-Investigator: Pascal Cintas, MD         
Sub-Investigator: Blandine Acket, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Laurent Guilleminault, MD University Hospital, Toulouse

Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03787511     History of Changes
Other Study ID Numbers: RC31/18/0423
2018-A03340-55 ( Other Identifier: ID-RCB )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
cough
diabetes
small fiber neuropathy

Additional relevant MeSH terms:
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Cough
Small Fiber Neuropathy
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases