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

Korábbi kezelés

• 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.

Más betegség

• Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).

Egyéb

• Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
• Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

• 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.