Comprehensive analysis of eosinophils and type 2 innate lymphoid cells in patients with severe asthma before and after mepolizumab treatment

Not Applicable

Recruiting

• Conditions: Severe eosinophilic asthma; Allergy, asthma, eosinophil; C08.127.108

• Registration Number: JPRN-jRCT1031230460
• Lead Sponsor: Miyata Jun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-19
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Other
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is to identify specific cellular changes of eosinophils and ILC2s and their benefit to predict mepolizumab treatment responsiveness.

Secondary Outcome Measures

Name	Time	Method
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.