Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)

NCT04816695 | Unknown

• 1 other identifier: 2020_0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Keywords

Volatile Organic Compounds

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation

  4 months

• Differences in the profiles of VOCs in exhaled air according to smoking habits

  4 months

• Compare VOC profiles to those of patients with severe COPD in a stable state

  4 months

Study Arms (1)

VOC analysis

EXPERIMENTAL

VOC analysis in exhaled air in patients hospitalised for COPD exacerbation

Device: VOC analysis

Interventions

VOC analysis DEVICE

VOC analysis in exhaled air with e-noses and mass spectrometry.

VOC analysis

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Re-hospitalization for severe exacerbation in the 6 months preceding the study;
• Chronic inflammatory disease (rheumatic, etc...) treated with systemic corticosteroid therapy;
• 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.

Sponsors & Collaborators

• Hopital Foch: lead
• Air Liquide SA: collaborator

Study Sites (1)

Foch hospital

Suresnes, 92151, France

RECRUITING

Study Officials

• Philippe Devillier, PhD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Devillier, PhD

CONTACT

0146252791; p.devillier@hopital-foch.com

Elisabeth Hulier-Ammar, PhD

CONTACT

drci-promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: March 17, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)