Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients (RhéMuc)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 4 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal