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Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| Smokers with COPD | Experimental | Subjects in this group are smokers or former smokers who have COPD Intervention: Bronchial Biopsy + 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial Biopsy | Procedure | Bronchial biopsies will be performed on all subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface density of active cilia | Surface density of active cilia | Day 0 + approximately 2 months of cell culture time |
| Measure | Description | Time Frame |
|---|---|---|
| Cilia beating frequency | The frequency at which cilia beat. | Day 0 + approximately 2 months of cell culture time |
| Mucus viscosity | The viscosity of mucus produced by cell cultures. |
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Inclusion criteria for non smoking controls:
Inclusion criteria for smokers without COPD:
Inclusion criteria for smokers with COPD:
Inclusion criteria for subjects with severe asthma:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Sophie Gamez, MD | Montpellier University Hospitals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Montpellier | 34295 | France |
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| 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. |
|
| Day 0 + approximately 2 months of cell culture time |
| Mucus elasticity | The elasticity of mucus produced by cell cultures. | Day 0 + approximately 2 months of cell culture time |
| Cilia beat orientation | The direction in which cilia beat | Day 0 + approximately 2 months of cell culture time |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
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