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

Asthma Clinical Trial

— RhéMuc  

Official title:

Demonstration of the Diagnostic Character of the Rheology of Mucus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03187860
• Other study ID #: RECHMPL18_0222
• Status: Terminated
• Phase: N/A
• Start date: June 19, 2019
• Est. completion date: December 26, 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pulmonary Disease, Chronic Obstructive
• Smoking

Intervention

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.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surface density of active cilia	Surface density of active cilia	Day 0 + approximately 2 months of cell culture time
Secondary	Cilia beating frequency	The frequency at which cilia beat.	Day 0 + approximately 2 months of cell culture time
Secondary	Mucus viscosity	The viscosity of mucus produced by cell cultures.	Day 0 + approximately 2 months of cell culture time
Secondary	Mucus elasticity	The elasticity of mucus produced by cell cultures.	Day 0 + approximately 2 months of cell culture time
Secondary	Cilia beat orientation	The direction in which cilia beat	Day 0 + approximately 2 months of cell culture time