Clinical trial · Interventional
Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
NCT05029349CI-TRIAL-00056221VOC-BPCOunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Obstructive Pulmonary Disease Severe | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VOC analysis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- VOC analysis
- description
- VOC analysis in exhaled air in patients hospitalised for stable severe COPD
- interventionNames
- Device: VOC analysis
Primary outcomes (2)
- measure
- Volatolom measurements by mass spectrometry
- timeFrame
- 4 months
- description
- Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
- measure
- Volatolom measurements by electronic-noses
- timeFrame
- 4 months
- description
- Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.