Status:

COMPLETED

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

Lead Sponsor:

MedImmune LLC

Collaborating Sponsors:

AstraZeneca

Conditions:

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

Eligibility:

All Genders

50+ years

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 cardiorespira...

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 respirat...

Eligibility Criteria

Inclusion

  • Key
  • 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

  • \- Participation in another clinical study involving the use of investigational product

Key Trial Info

Start Date :

July 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2014

Estimated Enrollment :

476 Patients enrolled

Trial Details

Trial ID

NCT01455402

Start Date

July 1 2010

End Date

May 1 2014

Last Update

July 9 2014

Active Locations (60)

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Page 1 of 15 (60 locations)

1

Research Site

Birmingham, Alabama, United States, 35294

2

Research Site

Fort Smith, Arkansas, United States, 72901

3

Research Site

Denver, Colorado, United States

4

Research Site

Bay Pines, Florida, United States

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