Chronic Obstructive Pulmonary DiseaseLAVOLEXNCT02529891
Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Measurement of VOC in exhaled air
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2014to 17 Oct 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with exacerbation of COPD and Healthy volonteers
Who may be able to join
- COPD stages 2 and 3 of GOLD score (30 ≤ forced expiratory volume at one second (FEV1) < 80% of predicted value),
- exacerbation confirmed clinically (increased dyspnea, cough or expectorations > 48 hours)
- No smoker (<100 cigarettes/year)
Who cannot join
- Diagnosis of COPD not confirmed.
- Instable clinical status with respiratory failure and indication of mechanical ventilation.
- Bronchodilator treatment changed
- Antibiotic treatment started in the 10 last days before admission
- Chronic inflammatory disease
- Any respiratory disease
- Oral corticosteroid treatment during the last month
Trial locations and contacts
1 site in 1 country.
About this study
Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated.
The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which reflect local or systemic inflammation and oxidative stress. The relationship between the presence of some of these compounds and the exacerbation of COPD has never been studied.
The aim of this study is to identify a cluster of VOC in COPD patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). Investigators also will seek for a relationship between VOC and the etiology of exacerbation (bacterial, viral, inflammatory).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Measurement of VOC in exhaled air
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Volatile Organic Compounds, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of VOC in exhaled airOther
Measurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | Patients with COPD, within 48h after hospital admission for exacerbation. Receives: Other: Measurement of VOC in exhaled air | |
| non-COPD patients | Healthy person of the entourage of COPD patients. Receives: Other: Measurement of VOC in exhaled air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectrum of VOC measured with a portable mass spectrometer system
Spectrum of VOC in exhaled air in patients with COPD compared to those of control subjects. It is measured with a portable mass spectrometer system.
Measured: Day 1 (within 48 hours after hospital admission for exacerbation of COPD)
Secondary outcomes (1)
Variation in VOC spectrum in COPD patients measured with a portable mass spectrometer system
Variation in VOC spectrum in COPD patients during exacerbation and in stable condition (3 months later). It is measured with a portable mass spectrometer system.
Measured: 3 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start8 Aug 2014
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Aide à la Recherche Médicale Ondaine et Environs
- Responsible party
- Sponsor
- Investigators
- Frederic COSTES, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529891
- Sponsor's protocol ID
- 1208090
- Other IDs
- 2012-A01072-41
- Acronym
- LAVOLEX
- Status last verified
- Oct 2017
- First submitted
- 19 Aug 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02529891
- Acronym / sponsor ID
- LAVOLEX / 1208090
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Volatile Organic Compounds, Exacerbation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Aide à la Recherche Médicale Ondaine et Environs
- Study start
- 8 Aug 2014 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 20 Aug 2015 (estimated)
- 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.
Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated.
The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which reflect local or systemic inflammation and oxidative stress. The relationship between the presence of some of these compounds and the exacerbation of COPD has never been studied.
The aim of this study is to identify a cluster of VOC in COPD patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). Investigators also will seek for a relationship between VOC and the etiology of exacerbation (bacterial, viral, inflammatory).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | – | Other: Measurement of VOC in exhaled airPatients with COPD, within 48h after hospital admission for exacerbation. |
| non-COPD patients | – | Other: Measurement of VOC in exhaled airHealthy person of the entourage of COPD patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with exacerbation of COPD and Healthy volonteers
Key inclusion criteria (3 listed)
- COPD stages 2 and 3 of GOLD score (30 ≤ forced expiratory volume at one second (FEV1) < 80% of predicted value),
- exacerbation confirmed clinically (increased dyspnea, cough or expectorations > 48 hours)
- No smoker (<100 cigarettes/year)
Key exclusion criteria (7 listed)
- Diagnosis of COPD not confirmed.
- Instable clinical status with respiratory failure and indication of mechanical ventilation.
- Bronchodilator treatment changed
- Antibiotic treatment started in the 10 last days before admission
- Chronic inflammatory disease
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 |
|---|---|---|
| Measurement of VOC in exhaled airMeasurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer | Other | COPD Patients, non-COPD patients |
Primary outcome
Spectrum of VOC measured with a portable mass spectrometer system
Time frame: Day 1 (within 48 hours after hospital admission for exacerbation of COPD)
Spectrum of VOC in exhaled air in patients with COPD compared to those of control subjects. It is measured with a portable mass spectrometer system.
1 secondary outcome
Variation in VOC spectrum in COPD patients measured with a portable mass spectrometer system
Time frame: 3 months after hospital discharge
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
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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.
Frederic COSTES, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 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: stopped early, as of the sponsor's last update on 19 Oct 2017. 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?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectrum of VOC measured with a portable mass spectrometer system (time frame: Day 1 (within 48 hours after hospital admission for exacerbation of COPD)). 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 19 Oct 2017.