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

Chronic Obstructive Pulmonary Disease Severe Clinical Trial

— VOC-BPCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029349
• Other study ID #: 2020_0003
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: June 13, 2023

Study information

• Verified date: January 2022
• Source: Hopital Foch
• Contact: Philippe Devillier, MD PhD
• Phone: 0146252791
• Email: p.devillier[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 13, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Severe
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• VOC analysis
VOC analysis in exhaled air with e-noses and mass spectrometry.

Locations

Country	Name	City	State
France	Foch hospital	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Foch	Air Liquide SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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