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

NCT05329194

CompletedPhase 4

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: Tezepelumab

Countries: United States

To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.

Eligibility overview

Sex: ALL

Age: 12 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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 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).
* 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.

Locations (37)

Mobile, Alabama, United States
Gilbert, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Rancho Mirage, California, United States
Westminster, California, United States
Colorado Springs, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Upper Marlboro, Maryland, United States
Ann Arbor, Michigan, United States
Ypsilanti, Michigan, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Hollis, New York, United States
Horseheads, New York, United States
Rochester, New York, United States
Valhalla, New York, United States
Chapel Hill, North Carolina, United States
Wilmington, North Carolina, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Altoona, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Warwick, Rhode Island, United States
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