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| ID | Type | Description | Link |
|---|---|---|---|
| D3150L00001 | Other Identifier | AstraZeneca AB |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease [AECOPD] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.
It is expected that this observational study will provide further understanding of the clinical impact and true incidence rates of RSV-associated hospitalizations and medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status in adults with COPD and/or CHF who are at increased risk for serious sequelae associated with RSV infections. As part of the evaluation, this study will collect symptom and physiologic data, and blood, nasal swab, and sputum in order to investigate the relationship of RSV infections with clinical endpoints.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status | Average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status | Average of 2 years | |
| Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths | Average of 2 years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
- Participation in another clinical study involving the use of investigational product
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The study population consists of adults with severe COPD and/or CHF who expect to have contact with children. Potential subjects will be identified through the medical record and extended invitations to volunteer.
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| Name | Affiliation | Role |
|---|---|---|
| Pam Griffin, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
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serum, whole blood, plasma, nasal swab, sputum
| Healthcare utilization for RSV-associated and all-cause medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status | Average of 2 years |
| Incidence of RSV-associated secondary bacterial pneumonia events | Average of 2 years |
| Fort Smith |
| Arkansas |
| 72901 |
| United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Bay Pines | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Council Bluffs | Iowa | 51503 | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Reno | Nevada | 89502 | United States |
| Research Site | Buffalo | New York | 14215-1199 | United States |
| Research Site | Mineola | New York | 11501 | United States |
| Research Site | Rochester | New York | 14621 | United States |
| Research Site | Chardon | Ohio | 44024 | United States |
| Research Site | Beaver | Pennsylvania | 15009 | United States |
| Research Site | Jefferson Hills | Pennsylvania | 15025 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Nashville | Tennessee | 35294 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Kingwood | Texas | 77339 | United States |
| Research Site | Marshfield | Wisconsin | United States |
| Research Site | Milwaukee | Wisconsin | 53295 | United States |
| Research Site | Pleven | Pleven | 5800 | Bulgaria |
| Research Site | Razgrad | Razgrad | 7200 | Bulgaria |
| Research Site | Sofia | Sofia | 1233 | Bulgaria |
| Research Site | Sofia | Sofia | 1431 | Bulgaria |
| Research Site | Sofia | Sofia | 1709 | Bulgaria |
| Research Site | Sofia | Sofia | Bulgaria |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Hamilton | Ontario | L8N 4A6 | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | G1G 3Z4 | Canada |
| Research Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| Research Site | Jindrichuv Hradec III | 377 01 | Czechia |
| Research Site | Kyjov | 697 01 | Czechia |
| Research Site | Liberec | 460 63 | Czechia |
| Research Site | Ostrava | 728 80 | Czechia |
| Research Site | Rokycany | 337 22 | Czechia |
| Research Site | Lyon | France | France |
| Research Site | Toulouse | France | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Berlin | 10367 | Germany |
| Research Site | Berlin | 12203 | Germany |
| Research Site | Leipzig | 04207 | Germany |
| Research Site | Leipzig | 04275 | Germany |
| Research Site | Mannheim | 68165 | Germany |
| Research Site | Ferrara | FE | 44121 | Italy |
| Research Site | Florence | FI | Italy |
| Research Site | Genova | GE | 16132 | Italy |
| Research Site | Pisa | PI | 56124 | Italy |
| Research Site | Parma | PR | 43125 | Italy |
| Research Site | Moscow | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Gothenburg | Sweden |
| Research Site | Linköping | Sweden |
| Research Site | Lund | Sweden |
| Research Site | Uppsala | Sweden |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| 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 |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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