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

NCT ID: NCT03187860

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2022-12-26

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Non-smoking controls

Subjects in this group have never smoked and have no known lung disorders.

Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)

Group Type: EXPERIMENTAL

Bronchial Biopsy

Intervention Type: PROCEDURE

Bronchial biopsies will be performed on all subjects.

ALI culture

Intervention Type: OTHER

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

Smokers without COPD

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

Group Type: EXPERIMENTAL

Bronchial Biopsy

Intervention Type: PROCEDURE

Bronchial biopsies will be performed on all subjects.

ALI culture

Intervention Type: OTHER

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

Smokers with COPD

Subjects in this group are smokers or former smokers who have COPD

Intervention: Bronchial Biopsy + ALI culture

Group Type: EXPERIMENTAL

Bronchial Biopsy

Intervention Type: PROCEDURE

Bronchial biopsies will be performed on all subjects.

ALI culture

Intervention Type: OTHER

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

Severe asthma

Subjects in this group are non-smokers or former (light) smokers who have severe asthma.

Intervention: Bronchial Biopsy + ALI culture

Group Type: EXPERIMENTAL

Bronchial Biopsy

Intervention Type: PROCEDURE

Bronchial biopsies will be performed on all subjects.

ALI culture

Intervention Type: OTHER

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

Interventions

Bronchial Biopsy

Bronchial biopsies will be performed on all subjects.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)
• 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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Sophie Gamez, MD

Role: STUDY_DIRECTOR

Montpellier University Hospitals

Locations

CHU Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL18_0222

Identifier Type: -

Identifier Source: org_study_id