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

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.

Study Overview

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

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.

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

Contacts and Locations

• Study Contact: Name: Philippe Devillier, MD PhD; Phone Number: +33 0146252791; Email: p.devillier@hopital-foch.com
• Study Contact Backup: Name: : Elisabeth Hulier-Ammar, PhD; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92151
    • Recruiting
    • Foch Hospital
    • Contact: Hélène Salvator, MD; Phone Number: 0146252955; Email: h.salvator@hopital-foch.com
    • Contact: Philippe Devillier, MD, PhD; Phone Number: 0146252791; Email: p.devillier@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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VOC analysis; VOC analysis in exhaled air in patients hospitalised for stable severe COPD	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 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.	4 months
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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),	4 months
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...)	4 months
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)	4 months
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)	4 months

Collaborators and Investigators

• Sponsor: Hopital Foch
• Collaborators: Air Liquide SA
• Investigators: Principal Investigator: Philippe Devillier, MD PhD, Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Anticipated): June 13, 2023
• Study Completion (Anticipated): June 13, 2023

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Severe; Chronic Obstructive Pulmonary Disease (COPD); Stable; Volatile Organic Compounds (VOC)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2020_0003

Drug and device information, study documents

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