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

NCT03187860 | Terminated

• 1 other identifier: RECHMPL18_0222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Smoking

Keywords

Bronchial epithelial cell; mucus; Air Liquid Interface

Outcome Measures

Primary Outcomes (1)

• Surface density of active cilia

  Surface density of active cilia

  Day 0 + approximately 2 months of cell culture time

Secondary Outcomes (4)

• Cilia beating frequency

  Day 0 + approximately 2 months of cell culture time

• Mucus viscosity

  Day 0 + approximately 2 months of cell culture time

• Mucus elasticity

  Day 0 + approximately 2 months of cell culture time

• Cilia beat orientation

  Day 0 + approximately 2 months of cell culture time

Study Arms (4)

Non-smoking controls

EXPERIMENTAL

Subjects in this group have never smoked and have no known lung disorders. Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)

Procedure: Bronchial Biopsy; Other: ALI culture

Smokers without COPD

EXPERIMENTAL

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

Procedure: Bronchial Biopsy; Other: ALI culture

Smokers with COPD

EXPERIMENTAL

Subjects in this group are smokers or former smokers who have COPD Intervention: Bronchial Biopsy + ALI culture

Procedure: Bronchial Biopsy; Other: ALI culture

Severe asthma

EXPERIMENTAL

Subjects in this group are non-smokers or former (light) smokers who have severe asthma. Intervention: Bronchial Biopsy + ALI culture

Procedure: Bronchial Biopsy; Other: ALI culture

Interventions

Bronchial Biopsy PROCEDURE

Bronchial biopsies will be performed on all subjects.

Non-smoking controls; Severe asthma; Smokers with COPD; Smokers without COPD

ALI culture OTHER

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

Non-smoking controls; Severe asthma; Smokers with COPD; Smokers without COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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)
• 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)
• The subject has given free and informed consent and signed the consent form

You may not qualify if:

• The subject has an extensive neoplastic disease
• The subject has another active lung disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection)
• Emergency situations (object extractions...)
• Subject consuming illicit drugs or alcohol
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Study Officials

• Anne Sophie Gamez, MD

  Montpellier University Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 15, 2017
• Study Start: June 19, 2019
• Primary Completion: April 26, 2022
• Study Completion: December 26, 2022
• Last Updated: June 12, 2023

Record last verified: 2022-09

Locations

FR (1)