An observational study in Asthma; Eosinophilic, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by University Hospital, Grenoble · Observational
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.
Patients included are those who have obtained the temporary authorization for nominative use for mepolizumab
Exclusion Criteria:
Patients will receive a subcutaneous injection of mepolizumab 100 mg every 4 weeks for one year, for a total of 12 injections
Drug: Mepolizumab
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.
Time frame: 13 months
Asthma control
Asthma Control Questionnaire (ACT)
Time frame: Every month during 13 months
Improving quality of life
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Every month during 13 months
Improvement of respiratory functional explorations, Forced Expiratory Volume
Forced Expiratory Volume
Time frame: 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.
Time frame: Assessed every month during 13 months
Improvement of respiratory functional explorations
Vital Capacity
Time frame: Every month during 13 months
Improvement of respiratory functional explorations
Forced Vital Capacity
Time frame: Every month during 13 months
Improvement of respiratory functional explorations
FEV/FVC
Time frame: Every month during 13 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble