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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01455402

Acronym

CD-1089

Enrollment

476

Registered

2011-10-20

Start date

2010-07-31

Completion date

2014-05-31

Last updated

2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status	Average of 2 years
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

Countries

Bulgaria, Canada, Czechia, France, Germany, Italy, Russia, Sweden, United States

Outcome results