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| Name | Class |
|---|---|
| Asthma Research Group Inc. | UNKNOWN |
| University Health Network, Toronto | OTHER |
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The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol [BGF] in a real-world setting.
This is a prospective, open label, non-interventional, single network of clinical practice centers study that will be conducted in routine clinical care in the pulmonary/ primary care practitioner (PCP) care setting in Ontario, Canada. Eligible patients will be enrolled into the study only following the treating physician's decision and patient agreement to initiate treatment with BGF. Patients will be observed for up to 6 months post-treatment initiation with BGF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budenoside/Glycopyrronium/Formoterol | Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budenoside/Glycopyrronium/Formoterol | Drug | Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the COPD Assessment Test (CAT) score | To estimate the change in COPD health status in patients initiating BGF after 12 weeks | 12 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic and clinical characteristics at baseline | To describe the demographic and clinical characteristics of patients in the study | At baseline |
| Change from baseline in CAT score after 24 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to severe COPD who are eligible for BGF therapy may be enrolled by physicians in primary care setting. The decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, is determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Windsor | Ontario | N8W 5V7 | Canada |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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To estimate the change in COPD health status after 24 weeks from treatment initiation
| 24 weeks from treatment initiation |
| Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-treatment initiation | To estimate the change in patient quality of life after 12 and 24 weeks of treatment initiation | 12 and 24 weeks after treatment initiation |
| Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24 | To estimate change in sleep quality following introduction of BGF | 12 and 24 weeks of treatment initiation |
| Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline | To describe the Responder Rate based on the CAT after 12 weeks of initiating treatment with BGF | 12 weeks treatment compared to baseline |
| The annualized rate of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit | To describe and compare the rate of moderate and severe exacerbations | Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months)) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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