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A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in the United States
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prompt | PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION |
| |
| DELAYED | PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION |
| |
| VERY DELAYED | PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGF | Drug | BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized COPD Exacerbation Event Rate | Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability; mean follow-up 462 days | Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Cardiopulmonary Event Rate | Annualized rates of cardiopulmonary events observed from index date (qualifying exacerbation event) through study completion (until end of data availability) | Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of all-cause mortality | Annualized incidence of all-cause mortality observed from index date (qualifying exacerbation event) through study completion (until end of data availability; mean follow-up 462 days | Annualized incidence of mortality during follow-up period until end of data availability; mean follow-up 462 days |
Inclusion Criteria:
1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
1 day of continuous enrollment following the qualifying index exacerbation date
Exclusion Criteria:
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The overall sample will include adult (aged 40+) COPD patients who have experienced a qualifying COPD exacerbation and eventually received treatment with BGF. Patients should not have prior single inhaler triple therapy (SITT) use during the 12-month period-baseline prior to the qualifying index exacerbation and prior to initiating BGF treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Pollack, MS | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AstraZeneca | Wilmington | Delaware | 19803 | United States |
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| Label | URL |
|---|---|
| D5980R00095 Redacted CSR Synopsis | 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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