臨床研究等提出・公開システム

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

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

Miyata Jun

Keio University School of Medicine

Shinanomachi 35, Shinjuku-ku, Tokyo

junmiyata.a2@keio.jp

Miyata Jun

Keio University School of Medicine

Shinanomachi 35, Shinjuku-ku, Tokyo

+81-3-3353-1211

junmiyata.a2@keio.jp

Recruiting

Nov. 19, 2023

Other

single arm study

open(masking not used)

uncontrolled control

single assignment

basic science

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

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

Both

Severe eosinophilic asthma

Allergy, asthma, eosinophil

C08.127.108

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

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.

+81-3-5363-3503

Sept. 01, 2023

No

none