SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study

SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study - SERPINE1 genotype and clinical outcomes during tezepelumab treatment in severe asthma: a prospective multicenter cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052531

Enrollment

Registered

2023-10-18

Start date

2023-11-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria 1) Patients with severe or refractory bronchial asthma whose asthma symptoms cannot be controlled by existing therapy and who will be treated with tezepelumab between the start of the study and November 1, 2024. 2) Patients 18 years of age or older.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Patients treated with bronchial thermoplasty 2) Patients with comorbidities requiring systemic steroids or immunosuppressive agents (except when systemic steroids are used as maintenance therapy for asthma) 3) Patients who are deemed inappropriate as research subjects by the investigator.

Design outcomes

Primary

Measure	Time frame
Annualized asthma exacerbation rate (AAER) during the 52 weeks after treatment initiation.	—

Secondary

Measure	Time frame
Asthma exacerbation frequency during weeks 0 to 12, and ACQ-6 score, FEV1, PEF, FeNO, blood eosinophil count, and total IgE at weeks 12 and 52.	—

Countries

Japan

Contacts

Public ContactSusumu Fukahori

Nagasaki University Hospital Respiratory Medicine

susumu-f@nagasaki-u.ac.jp+81958197273

Outcome results