Activation status of eosinophils in severe asthma patients treated with biologics - ACT study

Department of respiratory medicine, University of Tsukuba Hospital0 sites27 target enrollmentJuly 1, 2020

ConditionsSevere asthma Mild asthma

Overview

Phase: 未知
Intervention: Not specified
Conditions: Severe asthma Mild asthma
Sponsor: Department of respiratory medicine, University of Tsukuba Hospital
Enrollment: 27
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

July 1, 2020

End Date

February 28, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Department of respiratory medicine, University of Tsukuba Hospital

Eligibility Criteria

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\.