Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)
NCT ID: NCT04816695
Last Updated: 2021-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-03-17
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VOC analysis
VOC analysis in exhaled air in patients hospitalised for COPD exacerbation
VOC analysis
VOC analysis in exhaled air with e-noses and mass spectrometry.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VOC analysis
VOC analysis in exhaled air with e-noses and mass spectrometry.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* COPD treated for at least one year with one (or more successive) 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 corticosteroids) 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 in basal state before hospitalization (mMRC stage ≥ 2);
* Age between 40 and 85 years old;
* Perfect understanding of the French language;
* Have signed a consent form;
* Be affiliated to a health insurance plan.
Exclusion Criteria
* Chronic inflammatory disease (rheumatic, etc...) treated with 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);
* Cancer under treatment or follow-up;
* Pregnant women;
* Deprived of liberty or under guardianship.
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Air Liquide SA
INDUSTRY
Hopital Foch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philippe Devillier, PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital Foch
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Foch hospital
Suresnes, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Philippe Devillier, PhD
Role: primary
Hélène Salvator, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020_0005
Identifier Type: -
Identifier Source: org_study_id