Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure Clinical Trial
— CD-1089Official title:
An Observational Study to Assess Respiratory Syncytial Virus (RSV)-Associated Illness in Adults With Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)
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.
| Status | Completed |
| Enrollment | 476 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Key Inclusion Criteria: - Age 50 years or greater - Hospitalization due to worsening COPD and/or CHF - Severe COPD subjects (Global Initiative for Obstructive Lung Disease Stage III/IV); FEV1 <50% - Chronic CHF subjects (New York Heart Association Class III/IV or American College of Cardiology-American Heart Association Stage C/D); Ejection fraction < 40% - Expects to have direct contact with children at least once a month Key Exclusion Criteria: - Participation in another clinical study involving the use of investigational product |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Razgrad | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Sofia | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Saint-Romuald | Quebec |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Czech Republic | Research Site | Jindrichuv Hradec III | |
| Czech Republic | Research Site | Kyjov | |
| Czech Republic | Research Site | Liberec 1 | |
| Czech Republic | Research Site | Ostrava | |
| Czech Republic | Research Site | Rokycany | |
| France | Research Site | Lyon Cedex 4 | |
| France | Research Site | Nantes | |
| France | Research Site | Toulouse Cedex 4 | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Mannheim | |
| Italy | Research Site | Ferrara | FE |
| Italy | Research Site | Firenze | FI |
| Italy | Research Site | Genova | GE |
| Italy | Research Site | Parma | PR |
| Italy | Research Site | Pisa | PI |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Novosibirsk | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Linköping | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Uppsala | |
| United States | Research Site | Bay Pines | Florida |
| United States | Research Site | Beaver | Pennsylvania |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Chardon | Ohio |
| United States | Research Site | Council Bluffs | Iowa |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Fort Smith | Arkansas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Jefferson Hills | Pennsylvania |
| United States | Research Site | Kingwood | Texas |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Marshfield | Wisconsin |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Mineola | New York |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC | AstraZeneca |
United States, Bulgaria, Canada, Czech Republic, France, Germany, Italy, Russian Federation, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status | Average of 2 years | No | |
| Secondary | All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status | Average of 2 years | No | |
| Secondary | Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths | Average of 2 years | No | |
| Secondary | Healthcare utilization for RSV-associated and all-cause medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status | Average of 2 years | No | |
| Secondary | Incidence of RSV-associated secondary bacterial pneumonia events | Average of 2 years | No |