EUCTR2020-002341-42-IT进行中（未招募）1 期
A 24-week, multicenter, randomized, double-blind, parallel-arm, placebocontrolled extension study to assess the safety of CSJ117, when added to existing standard of care asthma therapy in patients =18 years of age who completed study CCSJ117A12201C - CCSJ117A12201E1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
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
- •- All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).
- •- Participants completing the Treatment period and Follow-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow-up period of study CSJ117A12201C
- •- Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 335
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.
- •- Participants who experienced a serious and drug-related AE in the prior study CSJ117A12201C.
- •- Participants receiving any prohibited medications.
- •- Participants with a history or current diagnosis of ECG abnormalities.
- •- Pregnant or nursing (lactating) women.
- •- Other protocol-defined exclusion criteria may apply
研究者
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