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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease Severe
• Interventions: Device: VOC analysis

• Registration Number: NCT05029349
• Lead Sponsor: Hopital Foch

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-31
• Study Start: 2021-10-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VOC analysis	VOC analysis	VOC analysis in exhaled air in patients hospitalised for stable severe COPD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Differences in the profiles of VOCs in the exhaled air according to the smoking habits	4 months	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	4 months	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 healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)	4 months	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)
Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)	4 months	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)

Trial Locations

Locations (1)

Foch hospital; 🇫🇷 Suresnes, France