Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
1. Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
Detailed description
1.Time to first moderate or severe COPD exacerbation during the 52-week treatment period, 2. Absolute change from baseline in HRQoL at Week 52, as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score, 3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52, 4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52, 5. Absolute change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52, 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period, 7. Absolute change from baseline in five-repetition sit-to-stand test (5STS) time (seconds) at Week 52, 8. Incidence and severity of adverse events, 9. Serum concentration of astegolimab at specified timepoints, 10. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study
Interventions
None listed
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to first moderate or severe COPD exacerbation during the 52-week treatment period, 2. Absolute change from baseline in HRQoL at Week 52, as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score, 3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52, 4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52, 5. Absolute change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52, 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period, 7. Absolute change from baseline in five-repetition sit-to-stand test (5STS) time (seconds) at Week 52, 8. Incidence and severity of adverse events, 9. Serum concentration of astegolimab at specified timepoints, 10. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Netherlands, Poland, Romania, Spain, Sweden