Severe asthma
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Severe asthma patients with 18 years or older who are scheduled to receive tezepelumab based on phsician's judge. And Tezepelumab will be treated according to the package insert 2. Patients who agree to receive tezepelumab in advance as a result of consultations with the attending physician
Exclusion criteria
Exclusion criteria: 1. Patients with serious complications such as uncontrolled heart disease, diabetes mellitus, or gastrointestinal hemorrhage 2. Patients with active local or systemic infection requiring treatment 3. Patients with a history of serious hypersensitivity 4. Patients whose enrollment in this study is considered to be difficult due to clinically significant psychiatric disorders 5. Other patients considered ineligible for this study by the principal investigator/sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During a 4-month observation period (up to 1 year), all participants will be divided into treatment responders and non-responders using FEV1.0, ACT score, GETE score, and frequency of acute exacerbations. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1, To analyze association between gene expression data from whole blood cells and effect of Tezepelumab, first, the difference in baseline gene expression between the responder and non-responder groups will be analyzed. In addition, changes in gene expression will be analyzed before and after tezepelumab treatment in the responder group and non-responder group, or in all patients. Thereafter, a cluster analysis will be performed by integrating gene sets with changes and clinical information. 2, If important genes involved in treatment response are identified, serum protein concentrations will be measured to determine whether these can be used as biomarkers. 3, To analyze the difference in the effect of Tezepelumab between type2 severe asthma patients and non-type 2 severe asthma patients in terms of clinical and gene expression information. 4, To clarify the effect of tezepelumab in terms of TSLP genetic polymorphisms. 5, Furthermore, using the R package, Coexpression analysis and consensus clustering will be performed, and analysis that is not bound by existing clinical information will also be performed. And the correlation between genetic information and clinical information will be analyzed. | — |
Countries
Japan
Contacts
Public ContactMasashi Matsuyama
Tsukuba university hospital Department of Respiratory Medicine
Outcome results
None listed