Severe asthma Mild asthma
Conditions
Interventions
None listed
Sponsors
Department of respiratory medicine, University of Tsukuba Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for all participants 1. All participants are over 20 years old and are required to have received a clinical diagnosis of eosinophilic asthma by a physician. 2. Informed consents from all participants are obtained. Specific inclusion criteria for each group Participant group 1 (N=5). 1. Mild eosinophilic asthma who have an elevated peripheral blood eosinophil count of 150 cells per uL or more at Visit 1 Participant group 2 (N=5 for each treatment, total N=15) 1. Severe eosinophilic asthma patients already being on the treatment of any biologic (mepolizumab, omalizumab, or dupilumab). These patients must be taking a biologic for at least 4 months with a good clinical response using GETE score. 2. These patients must have had at least one asthma exacerbation in the previous year before starting biologics, that required treatments with systemic glucocorticoids or some biologics while they were receiving treatment with high dose inhaled corticosteroid (ICS) with additional controllers. Participant group 3 (N=3 for each biologic, total N=9), 1. Severe asthma patients who are going to take mepolizumab, omalizumab, or dupilumab for the first time. 2. These patients have an elevated peripheral blood eosinophil count of 150 cells per uL or more at Visit 1. 3. These patients must have had at least one asthma exacerbation in the previous year that required treatments with systemic glucocorticoids or some biologics while they were receiving treatment with high dose inhaled corticosteroid (ICS) with additional controllers. 4. In the cases of severe asthma patients who have already been treated with some biologics, these patients never had a good asthma control with the currently used biologic. 5. Based on the clinical practice, the participation in this study should be considered after a new biologic was determined based on agreement between the attending physician and the patient. Only if consent can be obtained thereafter.
Exclusion criteria
Exclusion criteria: Exclusion criteria for all participant group 1. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. 2. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening. 3. Liver Disease: Known, pre-existing, unstable liver disease. 4. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. 5. Other Concurrent Medical Conditions: Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment. 6. Eosinophilic Diseases: Subjects with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndrome, Churg-Strauss syndrome, or eosinophilic esophagitis. 7. Pregnancy: Subjects who are pregnant or breastfeeding. Specific exclusion criteria for each group Participant group 3 (N = 3 for each biologic, total N=9), 1. Participants who have received any biologics (mepolizumab, omalizumab, benralizumab, or dupilumab) within 56 days before Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elucidation of the phenotypic heterogeneity of circulating eosinophils in severe asthma and mild asthma by performing RNA-seq in whole blood cells and purified blood eosinophils. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subsequent evaluation of the phenotypic alterations of blood eosinophils after treatment with the biologics mepolizumab, omalizumab, and dupilumab. | — |
Countries
Japan
Contacts
Public ContactMasashi Matsuyama
University of Tsukuba Hospital Department of respiratory medicine
Outcome results
None listed