Chronic obstructive pulmonary disease (COPD)
Conditions
Brief summary
Change from baseline in pre-dose morning FEV1 at week 28 (V7)
Detailed description
Change from baseline in 2-hour post-dose morning FEV1 at week 28 (V7), Rate of moderate and severe COPD exacerbations over 52 weeks of treatment, SGRQ response (Decrease from baseline in total score ≥4) at Week 28, Incidence of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious ADRs, serious AEs (SAEs), severe AEs, TEAEs leading to discontinuation from study drug, and TEAEs leading to death, Incidence of treatment-emergent pneumonia, Incidence of treatment-emergent major adverse cardiovascular events (MACE).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in pre-dose morning FEV1 at week 28 (V7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 2-hour post-dose morning FEV1 at week 28 (V7), Rate of moderate and severe COPD exacerbations over 52 weeks of treatment, SGRQ response (Decrease from baseline in total score ≥4) at Week 28, Incidence of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious ADRs, serious AEs (SAEs), severe AEs, TEAEs leading to discontinuation from study drug, and TEAEs leading to death, Incidence of treatment-emergent pneumonia, Incidence of treatment-emergent major adverse cardiovascular events (MACE). | — |
Countries
Bulgaria, Czechia, Hungary, Poland, Romania