Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOC analysis | Experimental | VOC analysis in exhaled air in patients with severe asthma treated by monoclonal antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOC analysis | Device | VOC analysis in exhaled air with e-noses and mass spectrometry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response | Clinically significant response defined by:
| 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | change from baseline profiles at 3, 6 and12 months post-baseline |
| Decrease of residual volume |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Hulier-Ammar | Contact | +33 1 46 25 11 75 | drci-promotion@hopital-foch.com |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Devillier | Pneumology department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Foch | Recruiting | Suresnes | 92150 | France |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Single Group Assignement
Not provided
Not provided
Not provided
Not provided
Predictive variations of a clinically relevant response with decrease of residual volume (RV) at 3, 6 and 12 months
| 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 | 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 | 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 | 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 | 1 day |
| Volatil Organic Compound (VOC) profiles according to patients' phenotype | Volatil Organic Compound (VOC) profiles according to patients' phenotype at the inclusion | 1 day |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |