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Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients (RhéMuc)

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ClinicalTrials.gov Identifier: NCT03187860
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Asthma Smoking Procedure: Bronchial Biopsy Other: ALI culture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Demonstration of the Diagnostic Character of the Rheology of Mucus
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Biopsy

Arm Intervention/treatment
Experimental: Non-smoking controls

Subjects in this group have never smoked and have no known lung disorders.

Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)

Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.

Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.

Experimental: Smokers without COPD

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

Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.

Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.

Experimental: Smokers with COPD

Subjects in this group are smokers or former smokers who have COPD

Intervention: Bronchial Biopsy + ALI culture

Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.

Other: ALI culture
Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.

Experimental: Severe asthma

Subjects in this group are non-smokers or former (light) smokers who have severe asthma.

Intervention: Bronchial Biopsy + ALI culture

Procedure: Bronchial Biopsy
Bronchial biopsies will be performed on all subjects.

Other: ALI culture
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 Measures :
  1. Surface density of active cilia [ Time Frame: Day 0 + approximately 2 months of cell culture time ]
    Surface density of active cilia


Secondary Outcome Measures :
  1. Cilia beating frequency [ Time Frame: Day 0 + approximately 2 months of cell culture time ]
    The frequency at which cilia beat.

  2. Mucus viscosity [ Time Frame: Day 0 + approximately 2 months of cell culture time ]
    The viscosity of mucus produced by cell cultures.

  3. Mucus elasticity [ Time Frame: Day 0 + approximately 2 months of cell culture time ]
    The elasticity of mucus produced by cell cultures.

  4. Cilia beat orientation [ Time Frame: Day 0 + approximately 2 months of cell culture time ]
    The direction in which cilia beat



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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 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

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): NCT03187860


Contacts
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Contact: Nicolas Molinari, PhD +33.(0)4.67.33.89.79 nicolas.molinari@inserm.fr

Locations
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France
Centre Hospitalier Universitaire de Montpellier Recruiting
Montpellier, France, 34295
Contact: Anne Sophie Gamez, MD    +334.67.33.59.32    as-gamez@chu-montpellier.fr   
Principal Investigator: Anne Sophie Gamez, MD         
Sub-Investigator: Arnaud Bourdin, MD,PhD         
Sub-Investigator: Romain Jean, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Anne Sophie Gamez, MD Montpellier University Hospitals

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03187860     History of Changes
Other Study ID Numbers: RECHMPL18_0222
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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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, Montpellier:
Bronchial epithelial cell
mucus
Air Liquid Interface

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive