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

Not Applicable

Terminated

• Conditions: Smoking; Asthma; Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT03187860
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-15
• Study Start: 2019-06-19
• Primary Completion: 2022-04-26
• Status Verified: 2022-09
• Study Completion: 2022-12-26
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surface density of active cilia	Day 0 + approximately 2 months of cell culture time	Surface density of active cilia

Secondary Outcome Measures

Name	Time	Method
Mucus viscosity	Day 0 + approximately 2 months of cell culture time	The viscosity of mucus produced by cell cultures.
Cilia beat orientation	Day 0 + approximately 2 months of cell culture time	The direction in which cilia beat
Cilia beating frequency	Day 0 + approximately 2 months of cell culture time	The frequency at which cilia beat.
Mucus elasticity	Day 0 + approximately 2 months of cell culture time	The elasticity of mucus produced by cell cultures.

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, France