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

Demonstration of the Diagnostic Character of the Rheology of Mucus

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03187860
Acronym
RhéMuc
Enrollment
30
Registered
2017-06-15
Start date
2019-06-19
Completion date
2022-12-26
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Pulmonary Disease, Chronic Obstructive, Smoking

Keywords

Bronchial epithelial cell, mucus, Air Liquid Interface

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.

Interventions

Bronchial biopsies will be performed on all subjects.

OTHERALI culture

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surface density of active ciliaDay 0 + approximately 2 months of cell culture timeSurface density of active cilia

Secondary

MeasureTime frameDescription
Cilia beating frequencyDay 0 + approximately 2 months of cell culture timeThe frequency at which cilia beat.
Mucus viscosityDay 0 + approximately 2 months of cell culture timeThe viscosity of mucus produced by cell cultures.
Mucus elasticityDay 0 + approximately 2 months of cell culture timeThe elasticity of mucus produced by cell cultures.
Cilia beat orientationDay 0 + approximately 2 months of cell culture timeThe direction in which cilia beat

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026