A study for observing severe asthma in patients treated with tezepelumab
Study identifier:D5180R00011
ClinicalTrials.gov identifier:NCT05677139
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
Asthma Control in Severe Asthma Patients Treated with Tezepelumab: A Prospective, Observational, Real-World Evidence Study (ASCENT)
Medical condition
asthma
Phase
Phase 4
Healthy volunteers
No
Study drug
-
Sex
All
Estimated Enrollment
550
Study type
Observational
Age
12 Years - 130 Years
Date
Study Start Date: 13 Dec 2022
Estimated Primary Completion Date: 31 Mar 2026
Estimated Study Completion Date: 31 Mar 2026
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
Sort by status
- All Statuses
- Recruiting
- Not yet recruiting
- Recruiting complete
- Completed
- Other
No locations available
| Arms | Assigned Interventions |
|---|---|
| Prospective Cohort Participants with severe uncontrolled asthma will receive tezepelumab. Relevant demographics, baseline clinical data, and asthma control questionnaire-6 (ACQ-6) will be retrospectively collected. All patient reported outcomes (PROs) will be prospectively collected. Other outcomes of interest (tezepelumab patterns of utilization, lung function, asthma exacerbations, medication use, and healthcare resource utilization [HRU]) will be collected at baseline (retrospective collection for 52-week pre-index period during enrolment) and prospectively collected during enrolment for participants who enroll into the study before the first dose of tezepelumab, and for a period of up to 52 weeks (at Weeks 4, 12, 24, and 52) after the index date. The index date is defined as the date when participants receive the first dose of tezepelumab. | - |
