A 24-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled 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

ovartis Pharma AG0 个研究点目标入组 375 人开始时间: 2021年10月27日最近更新: 2022年4月19日

研究概览

暂无简介。

•- 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

•- 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

发起方