Chronic Obstructive Pulmonary Disease ExacerbationVOC-BPCO-ExaNCT04816695
Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)
A study testing VOC analysis in people with Chronic Obstructive Pulmonary Disease Exacerbation, run by Hopital Foch at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation
- 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
- 17 Mar 2021to Nov 2022
- 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
- Patients with severe COPD (FEV ≤ 50% of theoretical values) hospitalized for exacerbation;
- COPD treated for at least one year with one (or more successive) 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 corticosteroids) 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 in basal state before hospitalization (mMRC stage ≥ 2);
- Age between 40 and 85 years old;
Show all 9Show fewer
- Perfect understanding of the French language;
- Have signed a consent form;
- Be affiliated to a health insurance plan.
Who cannot join
- Re-hospitalization for severe exacerbation in the 6 months preceding the study;
- Chronic inflammatory disease (rheumatic, etc...) treated with 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 under treatment or follow-up;
- 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, PhD, 0146252791, p.devillier@hopital-foch.com
Hélène Salvator, MD, h.salvator@hopital-foch.com
About this study
Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Total health insurance expenditure in 2017 for chronic respiratory diseases (excluding cystic fibrosis and cancers) was approximately €3.5 billion, including €1 billion for hospitalizations.
Hospitalizations are mainly related to a worsening of the disease (severe exacerbations mainly of viral and/or bacterial origin). Although the majority of exacerbations are treated on an outpatient basis with antibiotics and/or oral corticosteroids, those occurring in the most severe and often the oldest patients may require hospitalization. It should be noted that almost one out of two patients hospitalized for COPD exacerbation is re-hospitalized within six months; on the other hand, age and length of stay are the two main factors of mortality in the year following hospitalization for COPD in the Intensive Care Unit. Early detection of a worsening of the health status related to COPD could allow appropriate management and avoid at least part of the hospitalizations for exacerbation with a consequent reduction of the associated morbi-mortality.
The objective of this clinical study is to determine the evolution of the profile of volatile organic compounds (VOCs) present in the exhaled air (volatolom) in patients with severe COPD after hospitalization for exacerbation. This step should allow the identification of VOCs (modification of the volatolom) which would be associated with a severe COPD exacerbation, by comparing the volatolom at the acute phase of the exacerbation to the volatoloms during the progressive return to a stable state after hospitalization and to those of patients with a stabilized severe COPD (VOC-BPCO clinical study also sponsored by Foch Hospital)
Read the detailed description
Patients with severe COPD hospitalized for severe exacerbation (40 patients, ex-smokers or smokers) will be eligible for inclusion in the study.
It is planned to participate in 4 sessions (V1 to V4) of 45 minutes duration for V1 and 30 minutes maximum for V2 to V4, separated by 4 to 6 weeks. 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
- Volatile Organic Compounds
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 | Experimental | VOC analysis in exhaled air in patients hospitalised for COPD exacerbation Receives: Device: VOC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatolom variations analysis by mass spectrometry
Analysis of the volatolom by mass spectrometry under quiet breathing conditions during hospitalization for COPD exacerbation and during three successive visits, 4 to 6 weeks apart following hospitalization, upon gradual return to steady state.
Measured: 4 months
Volatolom variations analysis by electronic noses
Analysis of the volatolom by electronic noses under quiet breathing conditions during hospitalization for COPD exacerbation and during three successive visits, 4 to 6 weeks apart following hospitalization, upon gradual return to steady state.
Measured: 4 months
Secondary outcomes (3)
Differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation
Analyze the differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation (with or without antibiotic/ oral corticosteroid therapy, other criteria: ICU, non-invasive ventilation,...)
Measured: 4 months
Differences in the profiles of VOCs in exhaled air according to smoking habits
Analyze the differences in the profiles of VOCs in exhaled air according to smoking habits (ex-smokers versus active smokers),
Measured: 4 months
Compare VOC profiles to those of patients with severe COPD in a stable state
Comparison of VOC profiles determined from severe COPD patients included in the study versus VOC profiles of stable COPD patients who participated in the VOC-BPCO study (Sponsored by Foch Hospital)
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 posted25 Mar 2021
- Study start17 Mar 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (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 ExacerbationStudies 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, PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816695
- Sponsor's protocol ID
- 2020_0005
- Acronym
- VOC-BPCO-Exa
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)
- ClinicalTrials.gov ID
- NCT04816695
- Acronym / sponsor ID
- VOC-BPCO-Exa / 2020_0005
- Keywords
- Volatile Organic Compounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Air Liquide SA
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 25 Mar 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.
Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Total health insurance expenditure in 2017 for chronic respiratory diseases (excluding cystic fibrosis and cancers) was approximately €3.5 billion, including €1 billion for hospitalizations.
Hospitalizations are mainly related to a worsening of the disease (severe exacerbations mainly of viral and/or bacterial origin). Although the majority of exacerbations are treated on an outpatient basis with antibiotics and/or oral corticosteroids, those occurring in the most severe and often the oldest patients may require hospitalization. It should be noted that almost one out of two patients hospitalized for COPD exacerbation is re-hospitalized within six months; on the other hand, age and length of stay are the two main factors of mortality in the year following hospitalization for COPD in the Intensive Care Unit. Early detection of a worsening of the health status related to COPD could allow appropriate management and avoid at least part of the hospitalizations for exacerbation with a consequent reduction of the associated morbi-mortality.
The objective of this clinical study is to determine the evolution of the profile of volatile organic compounds (VOCs) present in the exhaled air (volatolom) in patients with severe COPD after hospitalization for exacerbation. This step should allow the identification of VOCs (modification of the volatolom) which would be associated with a severe COPD exacerbation, by comparing the volatolom at the acute phase of the exacerbation to the volatoloms during the progressive return to a stable state after hospitalization and to those of patients with a stabilized severe COPD (VOC-BPCO clinical study also sponsored by Foch Hospital)
Detailed description
Patients with severe COPD hospitalized for severe exacerbation (40 patients, ex-smokers or smokers) will be eligible for inclusion in the study.
It is planned to participate in 4 sessions (V1 to V4) of 45 minutes duration for V1 and 30 minutes maximum for V2 to V4, separated by 4 to 6 weeks. 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 | Experimental | Device: VOC analysisVOC analysis in exhaled air in patients hospitalised for COPD exacerbation |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with severe COPD (FEV ≤ 50% of theoretical values) hospitalized for exacerbation;
- COPD treated for at least one year with one (or more successive) 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 corticosteroids) 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 in basal state before hospitalization (mMRC stage ≥ 2);
Key exclusion criteria (7 listed)
- Re-hospitalization for severe exacerbation in the 6 months preceding the study;
- Chronic inflammatory disease (rheumatic, etc...) treated with 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 under treatment or follow-up;
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 variations analysis by mass spectrometry
Time frame: 4 months
Analysis of the volatolom by mass spectrometry under quiet breathing conditions during hospitalization for COPD exacerbation and during three successive visits, 4 to 6 weeks apart following hospitalization, upon gradual return to steady state.
Volatolom variations analysis by electronic noses
Time frame: 4 months
Analysis of the volatolom by electronic noses under quiet breathing conditions during hospitalization for COPD exacerbation and during three successive visits, 4 to 6 weeks apart following hospitalization, upon gradual return to steady state.
3 secondary outcomes
Differences in the profiles of VOCs in the exhaled air according to the treatment of the exacerbation
Time frame: 4 months
Differences in the profiles of VOCs in exhaled air according to smoking habits
Time frame: 4 months
Compare VOC profiles to those of patients with severe COPD in a stable state
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 30 Mar 2021.
- Individual participant dataSharing planned: No
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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, 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 Exacerbation, 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 9 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 30 Mar 2021. 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, 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 variations analysis 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 30 Mar 2021.