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Activation status of eosinophils in severe asthma patients treated with biologics

Not Applicable
Conditions
Severe asthma Mild asthma
Registration Number
JPRN-UMIN000040859
Lead Sponsor
Department of respiratory medicine, University of Tsukuba Hospital
Brief Summary

We evaluated the variation in gene expression profiles of peripheral blood eosinophils before and after starting treatment with mepolizumab. The expression of genes associated with IL-5/IL-5R signaling was decreased in eosinophils of patients treated with mepolizumab compared to that before starting mepolizumab. In contrast, genes particularly associated with type 1 eosinophils were upregulated after treatment with mepolizumab.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
27
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Subsequent evaluation of the phenotypic alterations of blood eosinophils after treatment with the biologics mepolizumab, omalizumab, and dupilumab.
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