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Chronic Cough and Small Fiber Neuropathy (CHROCOS)

Primary Purpose

Chronic Cough, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cough assessment
Neurological tests and cardiovascular tests
Skin biopsy
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Cough focused on measuring cough, diabetes, small fiber neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital LarreyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Diabetic patients with chronic cough

Diabetic patients without chronic cough

Arm Description

Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.

Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.

Outcomes

Primary Outcome Measures

Proportion of patients with small fiber neuropathy
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

proportion of patients with abnormal results of the thermotest
estimate the proportion of patients with abnormal results of the thermotest in each arm (with and without chronic cough)
proportion of patients with pathological results of the sudori-motor response
estimate the proportion of patients with pathological results of the sudori-motor response in each arm (with and without chronic cough)
the proportion of patients with abnormal results of cardiovascular tests
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)
proportion of patients with abnormal results of laser evoked potentials
estimate the proportion of patients with abnormal results of laser evoked potentials in each arm (with and without chronic cough)
proportion of patients with abnormal findings of cutaneous biopsy
estimate the proportion of patients with abnormal findings of cutaneous biopsy in in each arm (with and without chronic cough)
values of Leicester Cough Questionnaire (LCQ) in diabetic patients
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.
values of the DN4 questionnaire in diabetic patients
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.

Full Information

First Posted
December 21, 2018
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03787511
Brief Title
Chronic Cough and Small Fiber Neuropathy
Acronym
CHROCOS
Official Title
Chronic Cough and Small Fiber Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough, Type 2 Diabetes
Keywords
cough, diabetes, small fiber neuropathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic patients with chronic cough
Arm Type
Other
Arm Description
Diabetic patients with chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
Arm Title
Diabetic patients without chronic cough
Arm Type
Other
Arm Description
Diabetic patients without chronic cough defined by cough lasting for more than 8 weeks. Cough assessment, neurological tests and cardiovascular tests and skin biopsy.
Intervention Type
Other
Intervention Name(s)
Cough assessment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Neurological tests and cardiovascular tests
Intervention Description
Neurological tests : electromyography, thermotest, QSAR + cardiovascular test for Diabetic patients with chronic cough and Diabetic patients without chronic cough
Intervention Type
Other
Intervention Name(s)
Skin biopsy
Intervention Description
Skin biopsy to evaluate small fiber neuropathy for Diabetic patients with chronic cough and Diabetic patients without chronic cough
Primary Outcome Measure Information:
Title
Proportion of patients with small fiber neuropathy
Description
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).
Time Frame
6 month after inclusion visit
Secondary Outcome Measure Information:
Title
proportion of patients with abnormal results of the thermotest
Description
estimate the proportion of patients with abnormal results of the thermotest in each arm (with and without chronic cough)
Time Frame
6 month after inclusion visit
Title
proportion of patients with pathological results of the sudori-motor response
Description
estimate the proportion of patients with pathological results of the sudori-motor response in each arm (with and without chronic cough)
Time Frame
6 month after inclusion visit
Title
the proportion of patients with abnormal results of cardiovascular tests
Description
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)
Time Frame
6 month after inclusion visit
Title
proportion of patients with abnormal results of laser evoked potentials
Description
estimate the proportion of patients with abnormal results of laser evoked potentials in each arm (with and without chronic cough)
Time Frame
6 month after inclusion visit
Title
proportion of patients with abnormal findings of cutaneous biopsy
Description
estimate the proportion of patients with abnormal findings of cutaneous biopsy in in each arm (with and without chronic cough)
Time Frame
6 month after inclusion visit
Title
values of Leicester Cough Questionnaire (LCQ) in diabetic patients
Description
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.
Time Frame
6 month after inclusion visit
Title
values of the DN4 questionnaire in diabetic patients
Description
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.
Time Frame
6 month after inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Guilleminault, MD
Phone
05-67-77-18-50
Ext
33
Email
guilleminault.a@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Guilleminault, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Guilleminault, MD
First Name & Middle Initial & Last Name & Degree
Laurent Guilleminault, MD
First Name & Middle Initial & Last Name & Degree
Alain Didier, PH
First Name & Middle Initial & Last Name & Degree
Marion Dupuis, MD
First Name & Middle Initial & Last Name & Degree
Danielle Brouiquieres, MD
First Name & Middle Initial & Last Name & Degree
Vincent Fabry, MD
First Name & Middle Initial & Last Name & Degree
Anne Pavy-Le Traon, PH
First Name & Middle Initial & Last Name & Degree
Pascal Cintas, MD
First Name & Middle Initial & Last Name & Degree
Blandine Acket, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21292019
Citation
Chung KF. Chronic 'cough hypersensitivity syndrome': a more precise label for chronic cough. Pulm Pharmacol Ther. 2011 Jun;24(3):267-71. doi: 10.1016/j.pupt.2011.01.012. Epub 2011 Feb 1.
Results Reference
background
PubMed Identifier
28716044
Citation
De Santi F, Zoppini G, Locatelli F, Finocchio E, Cappa V, Dauriz M, Verlato G. Type 2 diabetes is associated with an increased prevalence of respiratory symptoms as compared to the general population. BMC Pulm Med. 2017 Jul 17;17(1):101. doi: 10.1186/s12890-017-0443-1.
Results Reference
background
PubMed Identifier
20354891
Citation
Pavy-Le Traon A, Fontaine S, Tap G, Guidolin B, Senard JM, Hanaire H. Cardiovascular autonomic neuropathy and other complications in type 1 diabetes. Clin Auton Res. 2010 Jun;20(3):153-60. doi: 10.1007/s10286-010-0062-x. Epub 2010 Mar 31.
Results Reference
background
PubMed Identifier
23889506
Citation
Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.
Results Reference
background

Learn more about this trial

Chronic Cough and Small Fiber Neuropathy

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