Glaxosmithkline Intellectual Property Development Ltd.

Primary objective: To evaluate the efficacy of GSK1070806 200 MG compared with placebo in adults with moderate to severe ATD. Secondary objectives: To evaluate the efficacy of GSK1070806 compared to placebo across a dose range by characterizing the longitudinal dose-response relationship in adults with moderate to severe ATD; To further evaluate the effects of GSK1070806 200 MG and the entire dose range compared to placebo in adults with moderate to severe ATD; To further evaluate the efficacy of GSK1070806 200 MG and the entire dose range compared to placebo in adults with moderate to severe ATD; To evaluate the effects of GSK1070806 200 MG and the entire dose range compared to placebo on health-related quality of life (HR-QOL), depression and anxiety, fatigue, sleep, WPAI, and pain measured by a battery of patient-reported outcomes PROs in adults with moderate to severe ATD; To evaluate the safety of GSK1070806 200 MG and the entire dose range in adults with moderate to severe ATD and across a dose range.

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.