Clinical trial NCT03988790: Evaluation of the Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air
Official title: Evaluation of Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignement
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response
timeFrame: 1 day
Secondary outcomes:
measure: Change of FEV and FEV/CV
timeFrame: change from baseline profiles at 3, 6 and12 months post-baseline
measure: Decrease of residual volume
timeFrame: change from baseline profiles at 3, 6 and12 months post-baseline
measure: Decrease of the daily dose of oral corticosteroids
timeFrame: change from baseline profiles at 1, 3, 6 and12 months post-baseline
measure: Reduction in the number of exacerbations
timeFrame: change from baseline profiles at 1, 3, 6 and12 months post-baseline
measure: Change before and after treatment
timeFrame: change from baseline profiles at 12 months post-baseline
measure: Change according to administered antibody
timeFrame: 1 day
measure: Volatil Organic Compound (VOC) profiles according to patients' phenotype
timeFrame: 1 day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Pneumology department
name: Philippe Devillier
role: PRINCIPAL_INVESTIGATOR
References: