Asthma; Eosinophilic
Conditions
Keywords
asthma, mepolizumab, corticosteroids
Brief summary
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.
Interventions
DRUGMepolizumab
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe eosinophilic asthma * Patient on inhaled therapy with inhaled corticosteroid and long-acting bronchodilator for at least 6 months * Patient under oral corticosteroid therapy (prednisolone or prednisone) for at least 6 months and unmodified in the last 4 weeks before the first injection * Patient able to provide informed and written consent * Obtaining the temporary authorization for nominative use for mepolizumab
Exclusion criteria
* Chronic pulmonary pathology other than asthma * Active neoplasia * Active liver disease * Serious and uncontrolled cardiovascular pathology (LVEF less than 30%, NYHA IV, ...) * Other eosinophilic pathology (Churg & Strauss syndrome, parasitic infection, ...) * Hypersensitivity to mepolizumab or excipient * Immunity disorders * Patient not affiliated to a social security system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. | 13 months | Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma control | Every month during 13 months | Asthma Control Questionnaire (ACT) |
| Improving quality of life | Every month during 13 months | Asthma Quality of Life Questionnaire (AQLQ) |
| Improvement of respiratory functional explorations, Forced Expiratory Volume | Every month during 13 months | Forced Expiratory Volume |
| Decrease in the number of exacerbations | Assessed every month during 13 months | 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. |
| Improvement of respiratory functional explorations | Every month during 13 months | Vital Capacity |
Countries
France
Outcome results
None listed