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The study was withdrawn due to a business decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD Arm | Participants with COPD with frequent exacerbations will be followed from the date of enrollment until death, loss to follow up, withdrawal of consent, or the end of the follow-up period, for up to 3 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease course of participants enrolled in COPD registry | Up to 3 years | |
| Treatment patterns of participants enrolled in COPD registry | 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. | Up to 3 years |
| Number of novel therapies for participants enrolled in COPD registry | Through medical records, the number and type of novel therapies would be assessed for participants enrolled in COPD registry. | Up to 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants at least 40 years of age that have had a COPD diagnosis for at least 12 months, are on stable maintenance therapy, and who have experienced at least two exacerbations in the last 12 months.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |