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

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)

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
• Intervention / Treatment: Device: VOC analysis

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) 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth HULIER-AMMAR, PhD; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92151
    • Recruiting
    • Foch Hospital
    • Contact: Hélène Salvator, MD; Email: h.salvator@hopital-foch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VOC analysis; VOC analysis in exhaled air in patients hospitalised for COPD exacerbation	Device: VOC analysis; VOC analysis in exhaled air with e-noses and mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Collaborators: Air Liquide SA

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Volatile Organic Compounds
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Disease Progression; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2020_0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No