Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
Annualized rate of moderate/severe exacerbations.
Detailed description
1. Time to first moderate/severe exacerbation., 2. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52., 3. Change from baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) total score at Week 52., 4. Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization, 5. Annualized Rate of Severe Exacerbations
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of moderate/severe exacerbations. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first moderate/severe exacerbation., 2. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52., 3. Change from baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS: COPD) total score at Week 52., 4. Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization, 5. Annualized Rate of Severe Exacerbations | — |
Countries
Belgium, Croatia, Denmark, France, Germany, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden