Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils
Conditions
Brief summary
Annualized rate of moderate or severe COPD exacerbations, where a COPD exacerbation is defined by symptomatic worsening of COPD requiring: • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or • Use of antibiotics; and/or • An inpatient hospitalization or death due to COPD
Detailed description
Annualized rate of severe COPD exacerbations, where a severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD, Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization due to COPD, Time to first COPD exacerbation, - SGRQ total and domain scores - CAT total score, E-RS:COPD total and domain scores, Change from baseline in pre-dose/pre-bronchodilator FEV1 at the study site, Mortality rate, Annual rate of hospitalizations due to COPD; Length of hospital stay; ICU days; annual rate of hospitalizations and emergency department visits combined due to COPD; annual rate of unscheduled outpatient visits including unscheduled visits to study sites due to COPD; and annual rate of unscheduled healthcare encounters due to COPD, - Serum benralizumab concentration - Anti-benralizumab antibodies
Interventions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate or severe COPD exacerbations, where a COPD exacerbation is defined by symptomatic worsening of COPD requiring: • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or • Use of antibiotics; and/or • An inpatient hospitalization or death due to COPD | — |
Secondary
| Measure | Time frame |
|---|---|
| Annualized rate of severe COPD exacerbations, where a severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD, Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization due to COPD, Time to first COPD exacerbation, - SGRQ total and domain scores - CAT total score, E-RS:COPD total and domain scores, Change from baseline in pre-dose/pre-bronchodilator FEV1 at the study site, Mortality rate, Annual rate of hospitalizations due to COPD; Length of hospital stay; ICU days; annual rate of hospitalizations and emergency department visits combined due to COPD; annual rate of unscheduled outpatient visits including unscheduled visits to study sites due to COPD; and annual rate of unscheduled healthcare encounters due to COPD, - Serum benralizumab concentration - Anti-benralizumab antibodies | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed