Clinical trial NCT05029349: Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
Official title: Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Severe
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Volatile Organic Compounds (VOC)
Severe
Stable
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: Air Liquide SA
First posted: 2021-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volatolom measurements by mass spectrometry
timeFrame: 4 months
measure: Volatolom measurements by electronic-noses
timeFrame: 4 months
Secondary outcomes:
measure: Differences in the profiles of VOCs in the exhaled air according to the smoking habits
timeFrame: 4 months
measure: Differences in the profiles of VOCs in the exhaled air according to the background therapy
timeFrame: 4 months
measure: Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)
timeFrame: 4 months
measure: Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)
timeFrame: 4 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch hospital
Study officials:
affiliation: Hopital Foch
name: Philippe Devillier, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: