This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
VOC analysis in exhaled air with e-noses and mass spectrometry.
Hôpital Foch
Suresnes, France
RECRUITINGChange 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
Time frame: 1 day
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: change from baseline profiles at 1, 3, 6 and12 months post-baseline
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Change before and after treatment
Change of Volatil Organic Compound (VOC) profiles before and after treatment whatever is the clinical answer
Time frame: 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
Time frame: 1 day
Volatil Organic Compound (VOC) profiles according to patients' phenotype
Volatil Organic Compound (VOC) profiles according to patients' phenotype at the inclusion
Time frame: 1 day