An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF
An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or 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.
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.
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