Chronic obstructive pulmonary disease (COPD)
Conditions
Brief summary
Time to first all-cause event (all-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Number of moderate or severe COPD exacerbations
Detailed description
Time to first COPD-related event (COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Time to first moderate and/or severe COPD exacerbation, Number of all-cause non-elective hospital readmissions, Number of ED visits, Number of COPD-related hospital readmissions, Number of COPD-related ED visits, Number of all-cause deaths, Number of COPD-related deaths, Occurrence of all-cause non-elective hospital readmissions, ED visits, or deaths, Occurrence of COPD-related hospital readmissions, ED visits, or deaths, Change from baseline in Chronic Airways Assessment Test (CAAT) score (CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease), Change from baseline in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score (EXACT is a patient-reported daily diary that captures respiratory symptoms in COPD using a 14-item questionnaire with a 0 to 100-point scale with higher scores indicating worse disease symptoms), Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first all-cause event (all-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Number of moderate or severe COPD exacerbations | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first COPD-related event (COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death), Time to first moderate and/or severe COPD exacerbation, Number of all-cause non-elective hospital readmissions, Number of ED visits, Number of COPD-related hospital readmissions, Number of COPD-related ED visits, Number of all-cause deaths, Number of COPD-related deaths, Occurrence of all-cause non-elective hospital readmissions, ED visits, or deaths, Occurrence of COPD-related hospital readmissions, ED visits, or deaths, Change from baseline in Chronic Airways Assessment Test (CAAT) score (CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease), Change from baseline in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score (EXACT is a patient-reported daily diary that captures respiratory sy | — |