Asthma
Conditions
Sponsors
AstraZeneca KKAstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented physician-diagnosed asthma for at least 12 months. - Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months. - Documented treatment with a total daily dose of either medium or high dose ICS (500 microgram or more 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 (<90% for subjects 12-17 yrs). - Evidence of asthma as documented by either: Documented historical reversibility of FEV1 12% or more and 200 mL or more in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 12% or more and 200 mL or more during screening. - Documented history of at least 2 asthma exacerbation events within 12 months. - ACQ-6 score 1.5 or more at screening and on day of randomization.
Exclusion criteria
Exclusion criteria: - Pulmonary disease other than asthma. - History of cancer. - History of a clinically significant infection. - Current smokers or subjects with smoking history 10 pack-yrs or more and subjects using vaping products, including electronic cigarettes. - 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. - Subject randomized in the current study or previous tezepelumab studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics - | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed