EUCTR2013-005615-27-IT进行中（未招募）1 期
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, PlaceboControlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumabin Adults and Adolescents with Asthma Inadequately Controlled on InhaledCorticosteroid Plus Long-Acting ß2-Agonist
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 770
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 12 -75 years
- •2. Documented physician-diagnosed asthma at least 12 months prior to enrollment.
- •3. Documented treatment with ICS at a total daily dose corresponding to =500µg fluticasone
- •propionate dry powder formulation equivalents and a LABA for at least 3 months.
- •4. Morning pre-BD FEV1 value of =40 and <80% value (<90% for patients 12 to 17 years of
- •age) of their PNV
- •5. Post-BD reversibility of =12% and =200 mL in FEV1
- •6. ACQ-6 score =1.5
- •7. At least 2 documented asthma exacerbations in the 12 months prior to the date of informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 77
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 653
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Clinically important pulmonary disease other than asthma
- •2. History of anaphylaxis following any biologic therapy
- •3. Hepatitis B, C or HIV
- •4. Pregnant or breastfeeding
- •5. History of cancer
- •6. Current tobacco smoking or a history of tobacco smoking for = 10 pack-years
- •7. Previous receipt of tralokinumab
研究者
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