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The primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma.
Asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and children. Despite current treatments that are often effective, 10% of patients are not controlled by inhaled therapies. These severe asthma require regular use of systemic corticosteroids in 30 to 40% of cases. In this context, the use of glucocorticoids is associated with many more or less serious adverse effects, but still affecting the patient's quality of life. Several treatments have already been proven to save systemic steroids (theophylline, anti-leukotrienes, golimumab ...). On the other hand, none is currently recommended because of a risk / benefit ratio that is too high.
Mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. It has recently been shown to be effective in reducing the daily dose of oral corticosteroids and in reducing exacerbations in these patients with severe eosinophilic asthma. It also reduces the number of eosinophils in the blood and sputum and improves the quality of life.
Patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one year, for a total of 12 injections.
In France, this treatment was subject to a Temporary Authorization for Nominative Use in severe eosinophilic asthma and is reserved for hospital use.
The injections will be done in HDJ Pneumology CHU Grenoble Alpes and patients will be followed monthly during injections and one month after the end of injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mepolizumab | Patients will receive a subcutaneous injection of mepolizumab 100 mg every 4 weeks for one year, for a total of 12 injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. | Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control | Asthma Control Questionnaire (ACT) | Every month during 13 months |
| Improving quality of life | Asthma Quality of Life Questionnaire (AQLQ) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients included are those who have obtained the temporary authorization for nominative use for mepolizumab
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| Name | Affiliation | Role |
|---|---|---|
| Margaux Isnard, Resident | University Hospital, Grenoble | Study Chair |
| Laure Geneletti, Resident | University Hospital, Grenoble | Study Chair |
| Audrey Lehmann, Ph | University Hospital, Grenoble | Study Chair |
| Pierrick Bedouch, PhD | University Hospital, Grenoble | Study Chair |
| Sébastien Chanoine | University Hospital, Grenoble | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | La Tronche | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25199060 | Background | Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8. | |
| 25199059 | Background | Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. |
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| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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| Every month during 13 months |
| Improvement of respiratory functional explorations, Forced Expiratory Volume | Forced Expiratory Volume | Every month during 13 months |
| Decrease in the number of exacerbations | An exacerbation is defined as an episode of progressive degradation, over a few days, of one or more clinical signs, as well as functional parameters of bronchial obstruction. | Assessed every month during 13 months |
| Improvement of respiratory functional explorations | Vital Capacity | Every month during 13 months |
| Improvement of respiratory functional explorations | Forced Vital Capacity | Every month during 13 months |
| Improvement of respiratory functional explorations | FEV/FVC | Every month during 13 months |
| D007960 |
| Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |