Status:
COMPLETED
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Asthma
Eligibility:
All Genders
12-130 years
Phase:
PHASE4
Brief Summary
To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
Detailed Description
This is a multicenter, single-arm, open-label, Post-authorization, Phase 4 study to assess the effectiveness of tezepelumab in the United States (US) among a real-world population of adults and adoles...
Eligibility Criteria
Inclusion
- Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
- Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
- Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment.
- Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)).
- Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
- Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
- Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists).
- Provision of signed and dated written informed consent form.
Exclusion
- Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
- Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
- Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment.
- Participation in an interventional clinical trial for asthma within 12 months prior to enrollment.
- Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT05329194
Start Date
April 29 2022
End Date
October 1 2025
Last Update
October 14 2025
Active Locations (37)
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1
Research Site
Mobile, Alabama, United States, 36608
2
Research Site
Gilbert, Arizona, United States, 85234
3
Research Site
Long Beach, California, United States, 90815
4
Research Site
Los Angeles, California, United States, 90017