Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)
Conditions
Brief summary
a)To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on change from baseline in FEV(1)AUC(0-4), b) To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on change from baseline in morning pre-dose trough FEV(1), c) To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on change from baseline in FEV(1) AUC(0-4), d) To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on change from baseline in morning pre-dose trough FEV(1
Detailed description
Safety: a) AEs b) Vital signs (systolic and diastolic blood pressure, pulse rate), Exploratory: a) Change from baseline in FEV(1) AUC(0-4) at TP 1, Exploratory: b) Time to onset defined as the first post-dose timepoint where the mean change from baseline in FEV1 exceeds 100 mL on TP 1, Exploratory: c) To demonstrate assay sensitivity via superiority of BGF MDI HFO relative to placebo MDI HFA on change from baseline in FEV(1)AUC(0-4) at Day 29, Exploratory: d) To demonstrate assay sensitivity via superiority of BGF MDIHFO relative to placebo MDI HFA on change from baseline in morning pre-dose trough FEV(1) at Day 29
Interventions
DRUGsuspension
DRUGSALBUTAMOL
DRUGPlacebo MDI HFA to match BGF MDI HFA
Sponsors
Astrazeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on change from baseline in FEV(1)AUC(0-4), b) To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on change from baseline in morning pre-dose trough FEV(1), c) To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on change from baseline in FEV(1) AUC(0-4), d) To demonstrate assay sensitivity via superiority of BGF MDI HFA relative to placebo MDI HFA on change from baseline in morning pre-dose trough FEV(1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: a) AEs b) Vital signs (systolic and diastolic blood pressure, pulse rate), Exploratory: a) Change from baseline in FEV(1) AUC(0-4) at TP 1, Exploratory: b) Time to onset defined as the first post-dose timepoint where the mean change from baseline in FEV1 exceeds 100 mL on TP 1, Exploratory: c) To demonstrate assay sensitivity via superiority of BGF MDI HFO relative to placebo MDI HFA on change from baseline in FEV(1)AUC(0-4) at Day 29, Exploratory: d) To demonstrate assay sensitivity via superiority of BGF MDIHFO relative to placebo MDI HFA on change from baseline in morning pre-dose trough FEV(1) at Day 29 | — |
Countries
Bulgaria, Hungary, Poland
Outcome results
None listed