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

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    40
  • sponsor
    University Hospital, Montpellier
Updated on 21 March 2022
COPD
pulmonary disease
asthma
forced expiratory volume
spirometry
respiratory disorder
obstructive lung disease

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.

Details
Condition Pulmonary Disease, Chronic Obstructive, Asthma, Smoking
Treatment Bronchial biopsy, ALI culture
Clinical Study IdentifierNCT03187860
SponsorUniversity Hospital, Montpellier
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Clear my responses

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