Chronic Obstructive Pulmonary Disease Severe Clinical Trial
— VOC-BPCOOfficial title:
Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 13, 2023 |
Est. primary completion date | June 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. 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; 2. History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study; 3. Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years 4. Severe dyspnea at baseline (mMRC stage = 2) 5. Aged 40-85 years inclusive 6. Fluency in French 7. A signed and dated written informed consent is obtained prior to participation 8. Affiliated to a health insurance plan Exclusion Criteria: 1. Severe exacerbation in the 4 months preceding the study 2. Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy, 3. Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion) 4. Unstable cardiovascular pathology (right or left heart failure, coronary artery disease); 5. Cancer 6. Pregnant women; 7. Deprived of liberty or under guardianship. |
Country | Name | City | State |
---|---|---|---|
France | Foch hospital | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Hopital Foch | Air Liquide SA |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volatolom measurements by mass spectrometry | Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart. | 4 months | |
Primary | Volatolom measurements by electronic-noses | Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart. | 4 months | |
Secondary | Differences in the profiles of VOCs in the exhaled air according to the smoking habits | Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to smoking habits (ex-smokers versus active smokers), | 4 months | |
Secondary | Differences in the profiles of VOCs in the exhaled air according to the background therapy | Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to the backgrounf therapy (with or without antibiotic/ oral corticosteroid therapy...) | 4 months | |
Secondary | Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch) | Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch) | 4 months | |
Secondary | Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch) | Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch) | 4 months |
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