COPD
Conditions
Brief summary
This registry will collect data on COPD, including the course of disease, treatment patterns, and potential new therapies. The registry will also track the experience of participants and caregivers in clinical practice.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of COPD for at least 12 months * On stable, standard of care (SoC) COPD maintenance therapy * Have experienced at least 2 exacerbations (moderate or severe) in the last 12 months, with one of them occurring while on SoC therapy
Exclusion criteria
* In palliative treatment * Participating in any interventional drug trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease course of participants enrolled in COPD registry | Up to 3 years | — |
| Treatment patterns of participants enrolled in COPD registry | Up to 3 years | Treatment patterns of participants enrolled in COPD registry would be monitored through medical records and the changes in the standard of care and potentially moving to other treatments such as biologics. |
| Number of novel therapies for participants enrolled in COPD registry | Up to 3 years | Through medical records, the number and type of novel therapies would be assessed for participants enrolled in COPD registry. |
| Health care utilization (HCU) by participants enrolled in COPD registry as measured by number of medical visits | Up to 3 years | — |
| HCU by participants enrolled in COPD registry as measured by types of medical care institutions visited | Up to 3 years | — |
| Quality of life (QoL) of participants enrolled in COPD registry as measured by the Chronic Airways Assessment Test (CAAT) | Up to 3 years | — |
| QoL of participants enrolled in COPD registry as measured by the EQ-5D Five Levels plus respiratory dimension (EQ-5D-5L+R) questionnaire | Up to 3 years | — |
| QoL of participants enrolled in COPD registry as measured by the Work Productivity and Impairment (WPAI)-COPD | Up to 3 years | — |
| QoL of participants enrolled in COPD registry as measured by the COPD treatment satisfaction questionnaire | Up to 3 years | — |
| QoL of participants enrolled in COPD registry as measured by the exacerbation experience questionnaire | Up to 3 years | — |
| Caregiver burden as measured by the Zarit Burden Interview 12-item (ZBI-12) | Up to 3 years | — |
| Caregiver burden as measured by the Work Productivity and Impairment (WPAI) questionnaire | Up to 3 years | — |
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed