Back to resultsCiliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients (RhéMuc)
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bronchial Biopsy
ALI culture
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive focused on measuring Bronchial epithelial cell, mucus, Air Liquid Interface
Eligibility Criteria
Inclusion criteria for non smoking controls:
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- The subject has never smoked
- No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
- No known respiratory disease
Inclusion criteria for smokers without COPD:
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- Smoker or former smoker (>= 30 pack years)
- No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
Inclusion criteria for smokers with COPD:
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- Smoker or former smoker (>= 30 pack years)
- Subject presenting with COPD: FEV1/FVC < 0.7 (based on spirometry values in the medical file and performed in the 3 months prior to inclusion)
- The subject requires bronchial fibroscopy (decision made by pneumologist)
- COPD of grade "2" or "3" according to GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
Inclusion criteria for subjects with severe asthma:
- The subject has given free and informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance program
- Non-smoker or former smoker (<10 pack years)
- Subject presenting with severe asthma: FEV1/FVC >= 0.7 and FEV1 < 80%
- The subjects requires bronchial fibroscopy (decision made by pneumologist)
Exclusion criteria:
- The subject has an extensive neoplastic disease
- The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
- The subject has had a recent psychiatric disorder (within one year prior to inclusion and documented by a specialist consultation)
- Emergency situations (object extractions...)
- Subject consuming illicit drugs or alcohol
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection, or is an adult under any kind of guardianship
- It is impossible to correctly inform the patient
- The subject cannot fluently read French
Sites / Locations
- CHU Montpellier
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Non-smoking controls
Smokers without COPD
Smokers with COPD
Severe asthma
Arm Description
Subjects in this group have never smoked and have no known lung disorders. Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
Subjects in this group are smokers or former smokers who do not have signs of obstructive disease (no chronic obstructive pulmonary disease (COPD)) Intervention: Bronchial Biopsy + ALI culture
Subjects in this group are smokers or former smokers who have COPD Intervention: Bronchial Biopsy + ALI culture
Subjects in this group are non-smokers or former (light) smokers who have severe asthma. Intervention: Bronchial Biopsy + ALI culture
Outcomes
Primary Outcome Measures
Surface density of active cilia
Surface density of active cilia
Secondary Outcome Measures
Cilia beating frequency
The frequency at which cilia beat.
Mucus viscosity
The viscosity of mucus produced by cell cultures.
Mucus elasticity
The elasticity of mucus produced by cell cultures.
Cilia beat orientation
The direction in which cilia beat
Full Information
NCT ID
NCT03187860
First Posted
June 12, 2017
Last Updated
June 8, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03187860
Brief Title
Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients
Acronym
RhéMuc
Official Title
Demonstration of the Diagnostic Character of the Rheology of Mucus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
December 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
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
This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.
Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. These will then be used to make observations concerning cilia and mucus rheology.
This is a first pilot study. The working hypothesis is that the largest group differences will be found for cilia densities; the latter metric was thus chosen as a primary criterion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
Keywords
Bronchial epithelial cell, mucus, Air Liquid Interface
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-smoking controls
Arm Type
Experimental
Arm Description
Subjects in this group have never smoked and have no known lung disorders.
Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
Arm Title
Smokers without COPD
Arm Type
Experimental
Arm Description
Subjects in this group are smokers or former smokers who do not have signs of obstructive disease (no chronic obstructive pulmonary disease (COPD))
Intervention: Bronchial Biopsy + ALI culture
Arm Title
Smokers with COPD
Arm Type
Experimental
Arm Description
Subjects in this group are smokers or former smokers who have COPD
Intervention: Bronchial Biopsy + ALI culture
Arm Title
Severe asthma
Arm Type
Experimental
Arm Description
Subjects in this group are non-smokers or former (light) smokers who have severe asthma.
Intervention: Bronchial Biopsy + ALI culture
Intervention Type
Procedure
Intervention Name(s)
Bronchial Biopsy
Intervention Description
Bronchial biopsies will be performed on all subjects.
Intervention Type
Other
Intervention Name(s)
ALI culture
Intervention Description
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.
Primary Outcome Measure Information:
Title
Surface density of active cilia
Description
Surface density of active cilia
Time Frame
Day 0 + approximately 2 months of cell culture time
Secondary Outcome Measure Information:
Title
Cilia beating frequency
Description
The frequency at which cilia beat.
Time Frame
Day 0 + approximately 2 months of cell culture time
Title
Mucus viscosity
Description
The viscosity of mucus produced by cell cultures.
Time Frame
Day 0 + approximately 2 months of cell culture time
Title
Mucus elasticity
Description
The elasticity of mucus produced by cell cultures.
Time Frame
Day 0 + approximately 2 months of cell culture time
Title
Cilia beat orientation
Description
The direction in which cilia beat
Time Frame
Day 0 + approximately 2 months of cell culture time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for non smoking controls:
The subject has given free and informed consent and signed the consent form
The subject is affiliated with or beneficiary of a medical insurance program
The subject has never smoked
No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
No known respiratory disease
Inclusion criteria for smokers without COPD:
The subject has given free and informed consent and signed the consent form
The subject is affiliated with or beneficiary of a medical insurance program
Smoker or former smoker (>= 30 pack years)
No obstructive breathing disorder (forced expiratory volume at one second (FEV1) >70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is > 0.7)
Inclusion criteria for smokers with COPD:
The subject has given free and informed consent and signed the consent form
The subject is affiliated with or beneficiary of a medical insurance program
Smoker or former smoker (>= 30 pack years)
Subject presenting with COPD: FEV1/FVC < 0.7 (based on spirometry values in the medical file and performed in the 3 months prior to inclusion)
The subject requires bronchial fibroscopy (decision made by pneumologist)
COPD of grade "2" or "3" according to GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
Inclusion criteria for subjects with severe asthma:
The subject has given free and informed consent and signed the consent form
The subject is affiliated with or beneficiary of a medical insurance program
Non-smoker or former smoker (<10 pack years)
Subject presenting with severe asthma: FEV1/FVC >= 0.7 and FEV1 < 80%
The subjects requires bronchial fibroscopy (decision made by pneumologist)
Exclusion criteria:
The subject has an extensive neoplastic disease
The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
The subject has had a recent psychiatric disorder (within one year prior to inclusion and documented by a specialist consultation)
Emergency situations (object extractions...)
Subject consuming illicit drugs or alcohol
The subject is in an exclusion period determined by a previous study
The subject is under judicial protection, or is an adult under any kind of guardianship
It is impossible to correctly inform the patient
The subject cannot fluently read French
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Sophie Gamez, MD
Organizational Affiliation
Montpellier University Hospitals
Official's Role
Study Director
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients
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