OZOMI
- Conditions
- severe asthma
- Registration Number
- JPRN-jRCT2080224709
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 66
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 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
Documented history of at least 1 asthma exacerbation events within 12 months
ACQ-6 score >=1.5 at screening or on day of registration
Pulmonary disease other than asthma
History of cancer
History of a clinically significant infection
Current smokers or subjects 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
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 safety<br>-
- Secondary Outcome Measures
Name Time Method