Demonstration of the Diagnostic Character of the Rheology of Mucus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surface density of active cilia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Non-smoking controls
Subjects in this group have never smoked and have no known lung disorders.
Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
干预措施: Bronchial Biopsy (Procedure)
Non-smoking controls
Subjects in this group have never smoked and have no known lung disorders.
Intervention: Bronchial Biopsy + ALI culture (Air Liquid Interface)
干预措施: ALI culture (Other)
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
干预措施: Bronchial Biopsy (Procedure)
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
干预措施: ALI culture (Other)
Smokers with COPD
Subjects in this group are smokers or former smokers who have COPD
Intervention: Bronchial Biopsy + ALI culture
干预措施: Bronchial Biopsy (Procedure)
Smokers with COPD
Subjects in this group are smokers or former smokers who have COPD
Intervention: Bronchial Biopsy + ALI culture
干预措施: ALI culture (Other)
Severe asthma
Subjects in this group are non-smokers or former (light) smokers who have severe asthma.
Intervention: Bronchial Biopsy + ALI culture
干预措施: Bronchial Biopsy (Procedure)
Severe asthma
Subjects in this group are non-smokers or former (light) smokers who have severe asthma.
Intervention: Bronchial Biopsy + ALI culture
干预措施: ALI culture (Other)
结局指标
主要结局
Surface density of active cilia
时间窗: Day 0 + approximately 2 months of cell culture time
Surface density of active cilia
次要结局
- Mucus viscosity(Day 0 + approximately 2 months of cell culture time)
- Cilia beat orientation(Day 0 + approximately 2 months of cell culture time)
- Cilia beating frequency(Day 0 + approximately 2 months of cell culture time)
- Mucus elasticity(Day 0 + approximately 2 months of cell culture time)