A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting Beta 2-Agonist
- Conditions
- Inadequately Controlled Asthma
- Registration Number
- JPRN-jRCT2080223351
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
1. Documented physician-diagnosed asthma
2. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to 500 microgram or more fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
3. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of 40% or more of their Predicted Normal Value (PNV)
4. Asthma Control Questionnaire-6 (ACQ-6) score 1.5 or more
1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant of breastfeeding
5. History or cancer
6. Current tobacco smoking or a history or tobacco smoking for 10 pack-years or more
7. Previous receipt of tralokinumab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method