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

Completed

• Conditions: Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure

• Registration Number: NCT01455402
• Lead Sponsor: MedImmune LLC

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status	Average of 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden