PASSAGE
Trial Overview
Official Title
A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States (PASSAGE)
Study Purpose
To assess the effectiveness of tezepelumab in the United States (US) among a real-world population of adults participants with asthma requiring medium-dose to high-dose inhaled corticosteroids (ICS)
Diagnosis
Severe asthmaEligibility
- Male or female, older than 19 years
- Physician-diagnosed asthma for at least 12 months prior
- Use of medium- to high-dose inhaled corticosteroids for at least 12 months prior
- Use of additional asthma maintenance controller medications for at least 12 months prior
- History of at least 2 asthma exacerbations in the 12 months prior
- Cannot use biologic treatment for asthma within 4 months prior to consent
- Cannot be enrolled into another clinical trial for asthma within 12 months
Intervention
tezepelumab (Tezspire)
For more information, visit ClinicalTrials.gov.
Key Participation Requirements
Trial Location(s)
Gender
All
Age
19 years of age or older
Enrollment Status
Active, Not Recruiting
Phase
Phase IV
Methodist Health System Trial Code
NCT05329194