Status:
UNKNOWN
Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)
Lead Sponsor:
Hopital Foch
Collaborating Sponsors:
Air Liquide SA
Conditions:
Chronic Obstructive Pulmonary Disease Exacerbation
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
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 pa...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- Patients with severe COPD (FEV ≤ 50% of theoretical values) hospitalized for exacerbation;
- 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
- Re-hospitalization for severe exacerbation in the 6 months preceding the study;
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04816695
Start Date
March 17 2021
End Date
November 1 2022
Last Update
March 30 2021
Active Locations (1)
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1
Foch hospital
Suresnes, France, 92151