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

MedImmune LLC476 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

476

Conditions

Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (60)

Outcomes

Primary Outcomes

Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status