Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States

• Status: Not yet recruiting
• Trial end date: 2024-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Parexel

Criteria

Inclusion Criteria:

• 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 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.

• Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months. 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.

• 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).

• Completed the full course of COVID-19 vaccination at least 28 days prior to tezepelumab administration. Taking an approved vaccine booster is not a requirement to participate in this study.

• Provision of signed and dated written informed consent form.

Exclusion Criteria:

• 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).

• Prior biologic use for the treatment of asthma within 4 months or 5 half-lives (whichever is longer).

• Participation in an interventional clinical trial for asthma within 12 months.

• Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.