GlaxoSmithKline Intellectual Property Development Ltd.

The purpose of this study is to evaluate the efficacy and safety of FF/UMEC/VI compared with FF/VI administered once daily via dry powder inhaler for 12 weeks. The primary estimate is the difference in mean change from baseline in trough FEV1 at week 12 between the FF/UMEC/VI 100/62.5/25 group and the FF/VI 100/25 μg group in Chinese subjects with inadequately controlled asthma, regardless of discontinuation of study treatment unrelated to the pandemic or due to pandemic infection, and in the absence of discontinuation of study treatment due to indirect effects of the pandemic. Secondary estimates assess FEV1 as above, but for FF/UMEC/VI 200/62.5/25 compared with FF/VI 200/25 μg. The study population will be consistent with Study 205715 (CAPTAIN study), consisting of adult subjects (≥18 years) with a diagnosis of asthma according to the Global Initiative for Asthma [GINA, 2020]. In addition, these patients had to have poorly controlled asthma (ACQ-6 score ≥1.5) despite ICS/LABA maintenance therapy at the screening visit (Visit 1) and to have maintained daily ICS/LABA for at least 12 weeks and maintained asthma medications during the 6-week treatment period before Visit 0. At Visit 1, subjects also had to have a pre-bronchodilator (morning) FEV1 ≥30% and <85% of predicted normal values and be reversible.

The purpose of this study is to evaluate the efficacy and safety of FF/UMEC/VI compared with FF/VI administered once daily via dry powder inhaler for 12 weeks. The primary estimate is the difference in mean change from baseline in trough FEV1 at week 12 between the FF/UMEC/VI 100/62.5/25 group and the FF/VI 100/25 μg group in Chinese subjects with inadequately controlled asthma, regardless of discontinuation of study treatment unrelated to the pandemic or due to pandemic infection, and in the absence of discontinuation of study treatment due to indirect effects of the pandemic. Secondary estimates assess FEV1 as above, but for FF/UMEC/VI 200/62.5/25 compared with FF/VI 200/25 μg. The study population will be consistent with Study 205715 (CAPTAIN study), consisting of adult subjects (≥18 years) with a diagnosis of asthma according to the Global Initiative for Asthma [GINA, 2020]. In addition, these patients had to have poorly controlled asthma (ACQ-6 score ≥1.5) despite ICS/LABA maintenance therapy at the screening visit (Visit 1) and to have maintained daily ICS/LABA for at least 12 weeks and maintained asthma medications during the 6-week treatment period before Visit 0. At Visit 1, subjects also had to have a pre-bronchodilator (morning) FEV1 ≥30% and <85% of predicted normal values and be reversible.