Severe eosinophilic asthma Allergy, asthma, eosinophil
Conditions
Interventions
None listed
Sponsors
Miyata Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with severe eosinophilic asthma that is defined as blood eosinophil counts >=150 cells/mm3 at enrollment and/or blood eosinophil counts >=300 cells/mm3 before the study (from the date at diagnosis of asthma to the enrollment date of this study) will be included in this study. They meet all of the following criteria. - The therapeutic management using high-dose ICS (Fluticasone propionate equivalent to >=1000 microgram/day or fluticasone furan carboxylic acid equivalent to >= 200 microgram/day) and >= 2 long-term management medicines (LABA, leukotriene receptor antagonist, theophylline, or LAMA). - Male and female between 18 and 80 years of age inclusive - <150 kg at weight. - The patient has provided written informed consent Healthy volunteers will be included in this study. They meet all of the following criteria. - The one has no history of specific diseases. - Male and female between 18 and 80 years of age inclusive - <150 kg at weight. - The patient has provided written informed consent
Exclusion criteria
Exclusion criteria: Patients are NOT eligible for this study if they met any of the following criteria: - Has previously been treated with mepolizumab before the study - Has a history of acute viral infection up to 4 weeks prior to blood sampling - Has been treated with systemic corticosteroids including methylprednisolone up to 4 weeks prior to blood sampling - History of widespread lung disease - Has cancer/malignancy under treatment - During the period of pregnancy - Individuals whom the principal investigators judge as inappropriate registers Healthy volunteers are NOT eligible for this study if they met any of the following criteria: - Has a history of acute viral infection up to 4 weeks prior to blood sampling - Individuals whom the principal investigators judge as inappropriate registers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is to identify specific cellular changes of eosinophils and ILC2s and their benefit to predict mepolizumab treatment responsiveness. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint is to evaluate the molecular differences and similarities of eosinophils and ILC2s between patients after treatment and healthy donors for understanding of cellular reversibility by mepolizumab. | — |
Contacts
Public ContactJun Miyata
Keio University School of Medicine
Outcome results
None listed