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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- Sponsor
- MedImmune LLC
- Enrollment
- 476
- Locations
- 1
- Primary Endpoint
- Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Participation in another clinical study involving the use of investigational product
Outcomes
Primary Outcomes
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
Time Frame: Average of 2 years
Secondary Outcomes
- Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths(Average of 2 years)
- 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)
- All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status(Average of 2 years)