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Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease) (VOC-BPCO)

Primary Purpose

Chronic Obstructive Pulmonary Disease Severe

Status
Recruiting
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 Severe focused on measuring Chronic Obstructive Pulmonary Disease (COPD), Volatile Organic Compounds (VOC), Severe, Stable

Eligibility Criteria

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

Inclusion Criteria:

  1. Severe COPD (FEV ≤ 50% of theoretical values)

    • stable for at least two months,
    • treated for at least one year with one (or more successively) 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;
  2. History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
  3. Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
  4. Severe dyspnea at baseline (mMRC stage ≥ 2)
  5. Aged 40-85 years inclusive
  6. Fluency in French
  7. A signed and dated written informed consent is obtained prior to participation
  8. Affiliated to a health insurance plan

Exclusion Criteria:

  1. Severe exacerbation in the 4 months preceding the study
  2. Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy,
  3. Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion)
  4. Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
  5. Cancer
  6. Pregnant women;
  7. Deprived of liberty or under guardianship.

Sites / Locations

  • Foch hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

VOC analysis

Arm Description

VOC analysis in exhaled air in patients hospitalised for stable severe COPD

Outcomes

Primary Outcome Measures

Volatolom measurements by mass spectrometry
Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
Volatolom measurements by electronic-noses
Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.

Secondary Outcome Measures

Differences in the profiles of VOCs in the exhaled air according to the smoking habits
Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to smoking habits (ex-smokers versus active smokers),
Differences in the profiles of VOCs in the exhaled air according to the background therapy
Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to the backgrounf therapy (with or without antibiotic/ oral corticosteroid therapy...)
Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)
Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)
Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)
Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)

Full Information

First Posted
July 7, 2021
Last Updated
January 13, 2022
Sponsor
Hopital Foch
Collaborators
Air Liquide SA
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1. Study Identification

Unique Protocol Identification Number
NCT05029349
Brief Title
Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
Acronym
VOC-BPCO
Official Title
Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
June 13, 2023 (Anticipated)
Study Completion Date
June 13, 2023 (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
This is a prospective interventional study to determine whether the profile of volatile organic compounds (VOCs) present in exhaled air (VOLATOLOM) is reproducible in stable severe COPD (Chronic Obstructive Pulmonary Disease) patients.
Detailed Description
After being informed about the study, all patients giving written informed consent and meeting the eligibility criteria will undergo 4 visits spaced 4 to 6 weeks apart. The first visit V1 will be about 45 minutes duration. The others ones (V2 to V4) will be about 30 minutes duration. 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 Severe
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Volatile Organic Compounds (VOC), Severe, Stable

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
Other
Arm Description
VOC analysis in exhaled air in patients hospitalised for stable severe COPD
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 measurements by mass spectrometry
Description
Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
Time Frame
4 months
Title
Volatolom measurements by electronic-noses
Description
Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Differences in the profiles of VOCs in the exhaled air according to the smoking habits
Description
Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to smoking habits (ex-smokers versus active smokers),
Time Frame
4 months
Title
Differences in the profiles of VOCs in the exhaled air according to the background therapy
Description
Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to the backgrounf therapy (with or without antibiotic/ oral corticosteroid therapy...)
Time Frame
4 months
Title
Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)
Description
Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)
Time Frame
4 months
Title
Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)
Description
Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)
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: Severe COPD (FEV ≤ 50% of theoretical values) stable for at least two months, treated for at least one year with one (or more successively) 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 corticosteroid therapy) 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 at baseline (mMRC stage ≥ 2) Aged 40-85 years inclusive Fluency in French A signed and dated written informed consent is obtained prior to participation Affiliated to a health insurance plan Exclusion Criteria: Severe exacerbation in the 4 months preceding the study Chronic inflammatory disease (rheumatic, etc.) treated with long-term 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 Pregnant women; Deprived of liberty or under guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Devillier, MD 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, MD 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, MD, PhD
Phone
0146252791
Email
p.devillier@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
Hélène Salvator, MD
Phone
0146252955
Email
h.salvator@hopital-foch.com

12. IPD Sharing Statement

Learn more about this trial

Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)

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