AsthmaZina-VOCNCT03988790
Evaluation of the Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air
A study testing VOC analysis in people with Asthma, run by Hopital Foch at 1 site in France.
Trial summary
This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- 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
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2018to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged > 18 years old
- patient with severe asthma who respond to the indication of monoclonal antibody therapy according to SPC and management criteria fixed by Transparency Committee
- signed informed consent
- patient with healthcare insurance
Who cannot join
- patient not responding to the criteria for the good use of monoclonal antibody in severe asthma
- contraindication to one of monoclonal antibody treatment according to SPC (hypersensitivity to one of compounds)
- patient unable to perform a slow vital capacity
- patient with long-term oxygen therapy , under invasive ventilation
- pregnant women
- patient deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Foch
Suresnes, 92150
Philippe Devillier, + 33 1 46 25 27 91, p.devillier@hopital-foch.com
About this study
Official title: Evaluation of Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air
This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.
Read the detailed description
At least one in two patients treated by monoclonal antibody for severe asthma doesn't have satisfying result after 6 months of treatment.
The evaluation of the answer, and even better the answer prediction, are fundamental issues for medico-economic plan as part of these innovative therapeutics.
The interest of the use of VOC as diagnostic or prognostic tool in patients with tumoral thoracic pathology or bronchial or pulmonary vascular diseases has been demonstrated.
VOC analysis will be performed using two different techniques: electronic nose and masse spectrometry. At each visit, in addition to the usual assessment, patients will have two non-invasives collections of exhaled air, one for electronic nose analysis and one for masse spectrometry analysis.
- Conditions
- Asthma
- Being tested
- VOC analysis
- Medical subject headings
- Asthma
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 with severe asthma treated by monoclonal antibody Receives: Device: VOC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response
Clinically significant response defined by:
- reduction of 50% of number of exacerbations treated by oral corticosteroids after 12 months of treatment compared to the number of exacerbation during the previous year AND/OR
- increase of 3 points (MCID according to Schartz and al 2009) of ACT score after 3 months of treatment and maintained at 6 months
Measured: 1 day
Secondary outcomes (7)
Change of FEV and FEV/CV
Predictive variations of a clinically relevant response with improvement of FEV and FEV/CV at 3, 6 and 12 months
Measured: change from baseline profiles at 3, 6 and12 months post-baseline
Decrease of residual volume
Predictive variations of a clinically relevant response with decrease of residual volume (RV) at 3, 6 and 12 months
Measured: change from baseline profiles at 3, 6 and12 months post-baseline
Decrease of the daily dose of oral corticosteroids
Predictive variations of a clinically relevant response with decrease of the daily dose of oral corticosteroids for corticosteroid-dependent patients at 1, 3, 6 and 12 months
Measured: change from baseline profiles at 1, 3, 6 and12 months post-baseline
Reduction in the number of exacerbations
50% reduction in the number of exacerbations treated with oral steroids after 6 months of treatment compared to the number of exacerbations in the previous year OR a 3 point increase in the ACT (Asthma Control Test) score after 3 months of treatment maintained at 6 months OR increase of GETE (global evaluation of treatment effectiveness) score at 1, 3, 6 and 12 months
Measured: change from baseline profiles at 1, 3, 6 and12 months post-baseline
Change before and after treatment
Change of Volatil Organic Compound (VOC) profiles before and after treatment whatever is the clinical answer
Measured: change from baseline profiles at 12 months post-baseline
Change according to administered antibody
Change of Volatil Organic Compound (VOC) profiles according to administered antibody
Measured: 1 day
Volatil Organic Compound (VOC) profiles according to patients' phenotype
Volatil Organic Compound (VOC) profiles according to patients' phenotype at the inclusion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start4 Dec 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Model description
- Single Group Assignement
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Devillier, Principal investigator, Pneumology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988790
- Sponsor's protocol ID
- 2018_0075
- Acronym
- Zina-VOC
- Status last verified
- Feb 2021
- First submitted
- 6 Jun 2019
- Last updated
- 16 Feb 2021
- 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 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air
- ClinicalTrials.gov ID
- NCT03988790
- Acronym / sponsor ID
- Zina-VOC / 2018_0075
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Jun 2019 (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 study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.
Detailed description
At least one in two patients treated by monoclonal antibody for severe asthma doesn't have satisfying result after 6 months of treatment.
The evaluation of the answer, and even better the answer prediction, are fundamental issues for medico-economic plan as part of these innovative therapeutics.
The interest of the use of VOC as diagnostic or prognostic tool in patients with tumoral thoracic pathology or bronchial or pulmonary vascular diseases has been demonstrated.
VOC analysis will be performed using two different techniques: electronic nose and masse spectrometry. At each visit, in addition to the usual assessment, patients will have two non-invasives collections of exhaled air, one for electronic nose analysis and one for masse spectrometry analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignement
| Arm | Type | Receives |
|---|---|---|
| VOC analysis | Experimental | Device: VOC analysisVOC analysis in exhaled air in patients with severe asthma treated by monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient aged > 18 years old
- patient with severe asthma who respond to the indication of monoclonal antibody therapy according to SPC and management criteria fixed by Transparency Committee
- signed informed consent
- patient with healthcare insurance
Key exclusion criteria (6 listed)
- patient not responding to the criteria for the good use of monoclonal antibody in severe asthma
- contraindication to one of monoclonal antibody treatment according to SPC (hypersensitivity to one of compounds)
- patient unable to perform a slow vital capacity
- patient with long-term oxygen therapy , under invasive ventilation
- pregnant women
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
Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response
Time frame: 1 day
Clinically significant response defined by: * reduction of 50% of number of exacerbations treated by oral corticosteroids after 12 months of treatment compared to the number of exacerbation during the previous year AND/OR * increase of 3 points (MCID according to Schartz and al 2009) of ACT score after 3 months of treatment and maintained at 6 months
7 secondary outcomes
Change of FEV and FEV/CV
Time frame: change from baseline profiles at 3, 6 and12 months post-baseline
Decrease of residual volume
Time frame: change from baseline profiles at 3, 6 and12 months post-baseline
Decrease of the daily dose of oral corticosteroids
Time frame: change from baseline profiles at 1, 3, 6 and12 months post-baseline
Reduction in the number of exacerbations
Time frame: change from baseline profiles at 1, 3, 6 and12 months post-baseline
Change before and after treatment
Time frame: change from baseline profiles at 12 months post-baseline
Change according to administered antibody
Time frame: 1 day
Volatil Organic Compound (VOC) profiles according to patients' phenotype
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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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.
Philippe Devillier principal investigator
Pneumology department
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 Asthma, 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 4 inclusion and 6 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 16 Feb 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 Elisabeth Hulier-Ammar (+33 1 46 25 11 75, drci-promotion@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response (time frame: 1 day). 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 16 Feb 2021.