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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-13

Study Completion Date

2023-06-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.

NCT04418973

Healthy Subjects

COMPLETED NA

Evaluation of the Reversibility of the Bronchial Obstruction by Impulse Oscillometry Technique in Chronic Obstructive Pulmonary Disease (COPD): Correlation With Functional Features Measured by Plethysmography and Dyspnoea

NCT02928744

COPD

TERMINATED NA

Oxygen Therapy Remote Monitoring in COPD Patients.

NCT05473780

Chronic Obstructive Pulmonary Disease

ACTIVE_NOT_RECRUITING

Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT03890224

Chronic Obstructive Pulmonary Disease COPD Exacerbation

RECRUITING NA

Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease

NCT06956742

Chronic Obstructive Pulmonary Disease (COPD)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease Severe

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VOC analysis

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

Group Type OTHER

VOC analysis

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VOC analysis

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No