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| Name | Class |
|---|---|
| Air Liquide SA | INDUSTRY |
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Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Total health insurance expenditure in 2017 for chronic respiratory diseases (excluding cystic fibrosis and cancers) was approximately €3.5 billion, including €1 billion for hospitalizations.
Hospitalizations are mainly related to a worsening of the disease (severe exacerbations mainly of viral and/or bacterial origin). Although the majority of exacerbations are treated on an outpatient basis with antibiotics and/or oral corticosteroids, those occurring in the most severe and often the oldest patients may require hospitalization. It should be noted that almost one out of two patients hospitalized for COPD exacerbation is re-hospitalized within six months; on the other hand, age and length of stay are the two main factors of mortality in the year following hospitalization for COPD in the Intensive Care Unit. Early detection of a worsening of the health status related to COPD could allow appropriate management and avoid at least part of the hospitalizations for exacerbation with a consequent reduction of the associated morbi-mortality.
The objective of this clinical study is to determine the evolution of the profile of volatile organic compounds (VOCs) present in the exhaled air (volatolom) in patients with severe COPD after hospitalization for exacerbation. This step should allow the identification of VOCs (modification of the volatolom) which would be associated with a severe COPD exacerbation, by comparing the volatolom at the acute phase of the exacerbation to the volatoloms during the progressive return to a stable state after hospitalization and to those of patients with a stabilized severe COPD (VOC-BPCO clinical study also sponsored by Foch Hospital)
Patients with severe COPD hospitalized for severe exacerbation (40 patients, ex-smokers or smokers) will be eligible for inclusion in the study.
It is planned to participate in 4 sessions (V1 to V4) of 45 minutes duration for V1 and 30 minutes maximum for V2 to V4, separated by 4 to 6 weeks. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOC analysis | Experimental | VOC analysis in exhaled air in patients hospitalised for COPD exacerbation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOC analysis | Device | VOC analysis in exhaled air with e-noses and mass spectrometry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volatolom variations analysis by mass spectrometry | Analysis of the volatolom by mass spectrometry under quiet breathing conditions during hospitalization for COPD exacerbation and during three successive visits, 4 to 6 weeks apart following hospitalization, upon gradual return to steady state. | 4 months |
| Volatolom variations analysis by electronic noses | Analysis of the volatolom by electronic noses under quiet breathing conditions during hospitalization for COPD exacerbation and during three successive visits, 4 to 6 weeks apart following hospitalization, upon gradual return to steady state. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation | Analyze the differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation (with or without antibiotic/ oral corticosteroid therapy, other criteria: ICU, non-invasive ventilation,...) | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Devillier, PhD | Contact | 0146252791 | +33 | p.devillier@hopital-foch.com |
| Elisabeth Hulier-Ammar, PhD | Contact | drci-promotion@hopital-foch.com |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Devillier, PhD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foch hospital | Recruiting | Suresnes | 92151 | France |
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| Differences in the profiles of VOCs in exhaled air according to smoking habits |
Analyze the differences in the profiles of VOCs in exhaled air according to smoking habits (ex-smokers versus active smokers), |
| 4 months |
| Compare VOC profiles to those of patients with severe COPD in a stable state | Comparison of VOC profiles determined from severe COPD patients included in the study versus VOC profiles of stable COPD patients who participated in the VOC-BPCO study (Sponsored by Foch Hospital) | 4 months |