Study to Evaluate Tezepelumab in Adults with Severe Uncontrolled Asthma - DIRECTION

Inclusion Criteria

• Inclusion Criteria:
• • Age. 18-80
• • Documented physician-diagnosed asthma for at least 12 months
• • Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
• • Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
• • At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
• • Morning pre-BD FEV1 <80% predicted normal
• • Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
• • Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
• • ACQ-6 score ≥1.5 at screening and on day of randomization
• Exclusion Criteria:
• • Pulmonary disease other than asthma.
• • History of cancer.
• • History of a clinically significant infection.
• • Current smokers or participants with smoking history ≥10 pack-yrs.
• • History of chronic alcohol or drug abuse within 12 months.
• • Hepatitis B, C or HIV.
• • Pregnant or breastfeeding.
• • History of anaphylaxis following any biologic therapy.
• • participant randomized in the current study or previous tezepelumab studies.