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
• Interventions: Procedure: Bronchial Biopsy; Other: ALI culture

• 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

Arm && Interventions

Group	Intervention	Description
Severe asthma	ALI culture	Subjects in this group are non-smokers or former (light) smokers who have severe asthma. Intervention: Bronchial Biopsy + ALI culture
Non-smoking controls	Bronchial Biopsy	Subjects in this group have never smoked and have no known lung disorders. Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
Smokers with COPD	Bronchial Biopsy	Subjects in this group are smokers or former smokers who have COPD Intervention: Bronchial Biopsy + ALI culture
Severe asthma	Bronchial Biopsy	Subjects in this group are non-smokers or former (light) smokers who have severe asthma. Intervention: Bronchial Biopsy + ALI culture
Non-smoking controls	ALI culture	Subjects in this group have never smoked and have no known lung disorders. Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
Smokers without COPD	Bronchial Biopsy	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
Smokers with COPD	ALI culture	Subjects in this group are smokers or former smokers who have COPD Intervention: Bronchial Biopsy + ALI culture
Smokers without COPD	ALI culture	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

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