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

Primary Purpose

Chronic Obstructive Pulmonary Disease Exacerbation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VOC analysis
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease Exacerbation focused on measuring Volatile Organic Compounds

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Foch hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VOC analysis

Arm Description

VOC analysis in exhaled air in patients hospitalised for COPD exacerbation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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,...)
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),
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)

Full Information

First Posted
March 23, 2021
Last Updated
March 25, 2021
Sponsor
Hopital Foch
Collaborators
Air Liquide SA
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1. Study Identification

Unique Protocol Identification Number
NCT04816695
Brief Title
Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)
Acronym
VOC-BPCO-Exa
Official Title
Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
Collaborators
Air Liquide SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Exacerbation
Keywords
Volatile Organic Compounds

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VOC analysis
Arm Type
Experimental
Arm Description
VOC analysis in exhaled air in patients hospitalised for COPD exacerbation
Intervention Type
Device
Intervention Name(s)
VOC analysis
Intervention Description
VOC analysis in exhaled air with e-noses and mass spectrometry.
Primary Outcome Measure Information:
Title
Volatolom variations analysis by mass spectrometry
Description
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.
Time Frame
4 months
Title
Volatolom variations analysis by electronic noses
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation
Description
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,...)
Time Frame
4 months
Title
Differences in the profiles of VOCs in exhaled air according to smoking habits
Description
Analyze the differences in the profiles of VOCs in exhaled air according to smoking habits (ex-smokers versus active smokers),
Time Frame
4 months
Title
Compare VOC profiles to those of patients with severe COPD in a stable state
Description
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)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Devillier, PhD
Phone
0146252791
Ext
+33
Email
p.devillier@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar, PhD
Email
drci-promotion@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier, PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier, PhD
Phone
0146252791
Email
p.devillier@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
Hélène Salvator, MD
Email
h.salvator@hopital-foch.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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