AVIGATOR
- Conditions
- Asthma
- Registration Number
- JPRN-jRCT2080223791
- Lead Sponsor
- AstraZeneca KKAstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 97
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method