Chronic Obstructive Pulmonary Disease SevereVOC-BPCONCT05029349
Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
A study testing VOC analysis in people with Chronic Obstructive Pulmonary Disease Severe, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe
- What is being tested?
- VOC analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2021to 13 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
- Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
- Severe dyspnea at baseline (mMRC stage ≥ 2)
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- Aged 40-85 years inclusive
- Fluency in French
- A signed and dated written informed consent is obtained prior to participation
- Affiliated to a health insurance plan
Who cannot join
- Severe exacerbation in the 4 months preceding the study
- Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy,
- Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion)
- Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
- Cancer
- Pregnant women;
- Deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
: Elisabeth Hulier-Ammar, PhD contact
France1 site, 1 recruiting
- Recruiting
Foch hospital
Suresnes, 92151
Philippe Devillier, MD, PhD, 0146252791, p.devillier@hopital-foch.com
Hélène Salvator, MD, 0146252955, h.salvator@hopital-foch.com
About this study
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.
Read the 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.
- Being tested
- VOC analysis
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Volatile Organic Compounds (VOC), Severe, Stable
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOC analysisDevice
VOC analysis in exhaled air with e-noses and mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| VOC analysis | Other | VOC analysis in exhaled air in patients hospitalised for stable severe COPD Receives: Device: VOC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
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.
Measured: 4 months
Secondary outcomes (4)
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),
Measured: 4 months
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...)
Measured: 4 months
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)
Measured: 4 months
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)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start13 Oct 2021
- Primary completion13 Jun 2023 (estimated)
- Study completion13 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Air Liquide SA
- Responsible party
- Sponsor
- Investigators
- Philippe Devillier, MD PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029349
- Sponsor's protocol ID
- 2020_0003
- Acronym
- VOC-BPCO
- Status last verified
- Jan 2022
- First submitted
- 7 Jul 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)
- ClinicalTrials.gov ID
- NCT05029349
- Acronym / sponsor ID
- VOC-BPCO / 2020_0003
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), Volatile Organic Compounds (VOC), Severe, Stable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Air Liquide SA
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 13 Jun 2023 (estimated)
- Study completion
- 13 Jun 2023 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VOC analysis | Other | Device: VOC analysisVOC analysis in exhaled air in patients hospitalised for stable severe COPD |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Severe COPD (FEV ≤ 50% of theoretical values)
- History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
- Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
- Severe dyspnea at baseline (mMRC stage ≥ 2)
- Aged 40-85 years inclusive
Key exclusion criteria (7 listed)
- Severe exacerbation in the 4 months preceding the study
- Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy,
- Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion)
- Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOC analysisVOC analysis in exhaled air with e-noses and mass spectrometry. | Device | VOC analysis |
Primary outcome
Volatolom measurements by mass spectrometry
Time frame: 4 months
Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
Volatolom measurements by electronic-noses
Time frame: 4 months
Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart.
4 secondary outcomes
Differences in the profiles of VOCs in the exhaled air according to the smoking habits
Time frame: 4 months
Differences in the profiles of VOCs in the exhaled air according to the background therapy
Time frame: 4 months
Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch)
Time frame: 4 months
Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
: Elisabeth Hulier-Ammar, PhD contact
Philippe Devillier, MD PhD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOC analysis in people with Chronic Obstructive Pulmonary Disease Severe, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Devillier, MD PhD (0146252791 ext. +33, p.devillier@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatolom measurements by mass spectrometry (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.