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

Hopital Foch

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease Severe

Treatments: Device: VOC analysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05029349

2020_0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

VOC analysis

Other group

Description:

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

Treatment:

Device: VOC analysis