Clinical trial NCT03187860: Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients
Official title: Demonstration of the Diagnostic Character of the Rheology of Mucus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Asthma
Smoking
Keywords: Bronchial epithelial cell
mucus
Air Liquid Interface
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Surface density of active cilia
timeFrame: Day 0 + approximately 2 months of cell culture time
Secondary outcomes:
measure: Cilia beating frequency
timeFrame: Day 0 + approximately 2 months of cell culture time
measure: Mucus viscosity
timeFrame: Day 0 + approximately 2 months of cell culture time
measure: Mucus elasticity
timeFrame: Day 0 + approximately 2 months of cell culture time
measure: Cilia beat orientation
timeFrame: Day 0 + approximately 2 months of cell culture time
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
Study officials:
affiliation: Montpellier University Hospitals
name: Anne Sophie Gamez, MD
role: STUDY_DIRECTOR
References: