Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma (Mepolizumab)
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|ClinicalTrials.gov Identifier: NCT03453021|
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : October 3, 2018
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.
|Condition or disease||Intervention/treatment|
|Asthma; Eosinophilic||Drug: Mepolizumab|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||27 participants|
|Target Follow-Up Duration:||13 Months|
|Official Title:||Effet du Mepolizumab Sur la décroissance de la corticothérapie systémique Chez Des Patients Avec un Asthme éosinophilique sévère Etude Observationnelle, Suivi de Cohorte Via Une ATU Nominative|
|Actual Study Start Date :||January 25, 2016|
|Actual Primary Completion Date :||October 31, 2017|
|Actual Study Completion Date :||October 31, 2017|
Patients will receive a subcutaneous injection of mepolizumab 100 mg every 4 weeks for one year, for a total of 12 injections
- Effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. [ Time Frame: 13 months ]Rate of decrease in systemic corticosteroids between the day of the first injection and one month after the last injection.
- Asthma control [ Time Frame: Every month during 13 months ]Asthma Control Questionnaire (ACT)
- Improving quality of life [ Time Frame: Every month during 13 months ]Asthma Quality of Life Questionnaire (AQLQ)
- Improvement of respiratory functional explorations, Forced Expiratory Volume [ Time Frame: Every month during 13 months ]Forced Expiratory Volume
- Decrease in the number of exacerbations [ Time Frame: 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 [ Time Frame: Every month during 13 months ]Vital Capacity
- Improvement of respiratory functional explorations [ Time Frame: Every month during 13 months ]Forced Vital Capacity
- Improvement of respiratory functional explorations [ Time Frame: Every month during 13 months ]FEV/FVC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453021
|University Hospital Grenoble|
|La Tronche, France, 38700|
|Study Chair:||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|