Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
试验速览
- 阶段
- 不适用
- 发起方
- Hopital Foch
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Volatolom measurements by mass spectrometry
研究概览
简要总结
This is a prospective interventional study to determine whether the profile of volatile organic compounds (VOCs) present in exhaled air (VOLATOLOM) is reproducible in stable severe COPD (Chronic Obstructive Pulmonary Disease) patients.
详细描述
After being informed about the study, all patients giving written informed consent and meeting the eligibility criteria will undergo 4 visits spaced 4 to 6 weeks apart.
The first visit V1 will be about 45 minutes duration. The others ones (V2 to V4) will be about 30 minutes duration.
All sessions will be carried out in the Pneumology Department of the Foch Hospital, volatolomics platform (Exhalomics®).
Exhalation collection will be performed at each visit in order to perform the volatolom analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe COPD (FEV ≤ 50% of theoretical values)
- •stable for at least two months,
- •treated for at least one year with one (or more successively) combination of at least two inhaled drugs: either a Long-Acting Beta2-Adrenergic bronchodilator (LABA) combined with a corticosteroid (CSI), or a LABA combined with a long-acting anti-cholinergic bronchodilator (LAMA), or a triple combination LABA/LAMA/CSI;
- •History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
- •Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
- •Severe dyspnea at baseline (mMRC stage ≥ 2)
- •Aged 40-85 years inclusive
- •Fluency in French
- •A signed and dated written informed consent is obtained prior to participation
- •Affiliated to a health insurance plan
排除标准
- •Severe exacerbation in the 4 months preceding the study
- •Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy,
- •Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion)
- •Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
- •Pregnant women;
- •Deprived of liberty or under guardianship.
结局指标
主要结局
Volatolom measurements by mass spectrometry
时间窗: 4 months
Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
Volatolom measurements by electronic-noses
时间窗: 4 months
Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
次要结局
- Differences in the profiles of VOCs in the exhaled air according to the smoking habits(4 months)
- Differences in the profiles of VOCs in the exhaled air according to the background therapy(4 months)
- Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)(4 months)
- Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)(4 months)