Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab

Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1, or FEV1≥400 mL variability over time, or positive result of branchial provocation test within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 1.

Other acceptable asthma controller includes LTRA, LAMA or theophylline 5. On stable MD/HD ICS (>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA stable for ≥2 months prior to enrollment 6. On stable LTRA or LAMA or theophylline (≥2 weeks) is allowed 7. Documented ACQ-5 ≥ 1.5 in Visit 1 8. Documented at least one exacerbation in the year prior to enrolment

A qualifying historical asthma exacerbation is a symptomatic worsening requiring systemic corticosteroid (i.e., oral, intravenous (IV) or intramuscular; any healthcare setting or temporary increase from a stable maintenance dose of oral corticosteroid) or that resulted in hospitalization or emergency room/urgent care visit.

Source documentation is required for physician-diagnosed asthma, ICS-LABA use and asthma exacerbations over the prior year. A patient verbal history suggestive of asthma symptoms and/or prior asthma exacerbations, but without supporting documentation, is not sufficient to satisfy these inclusion criteria.