An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF (CD-1089)

July 8, 2014 updated by: MedImmune LLC

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)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Research Site
      • Razgrad, Bulgaria, 7200
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Sofia, Bulgaria, 1709
        • Research Site
  • Canada
      • Quebec, Canada, G1G 3Z4
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
      • Saint-Romuald, Quebec, Canada, G6W 5M6
        • Research Site
  • Czech Republic
      • Jindrichuv Hradec III, Czech Republic, 377 01
        • Research Site
      • Kyjov, Czech Republic, 697 01
        • Research Site
      • Liberec 1, Czech Republic, 460 63
        • Research Site
      • Ostrava, Czech Republic, 728 80
        • Research Site
      • Rokycany, Czech Republic, 337 22
        • Research Site
  • France
      • Lyon Cedex 4, France
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Toulouse Cedex 4, France
        • Research Site
  • Germany
      • Berlin, Germany, 10367
        • Research Site
      • Berlin, Germany, 12203
        • Research Site
      • Leipzig, Germany, 04207
        • Research Site
      • Leipzig, Germany, 04275
        • Research Site
      • Mannheim, Germany, 68165
        • Research Site
  • Italy
    • FE
      • Ferrara, FE, Italy, 44121
        • Research Site
    • FI
      • Firenze, FI, Italy
        • Research Site
    • GE
      • Genova, GE, Italy, 16132
        • Research Site
    • PI
      • Pisa, PI, Italy, 56124
        • Research Site
    • PR
      • Parma, PR, Italy, 43125
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Florida
      • Bay Pines, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Research Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Research Site
    • New York
      • Buffalo, New York, United States, 14215-1199
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • Rochester, New York, United States, 14621
        • Research Site
    • Ohio
      • Chardon, Ohio, United States, 44024
        • Research Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Research Site
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 35294
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
      • Kingwood, Texas, United States, 77339
        • Research Site
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Research Site
      • Milwaukee, Wisconsin, United States, 53295
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adults with severe COPD and/or CHF who expect to have contact with children. Potential subjects will be identified through the medical record and extended invitations to volunteer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status
Time Frame: Average of 2 years
Average of 2 years
Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths
Time Frame: Average of 2 years
Average of 2 years
Healthcare utilization for RSV-associated and all-cause medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status
Time Frame: Average of 2 years
Average of 2 years
Incidence of RSV-associated secondary bacterial pneumonia events
Time Frame: Average of 2 years
Average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Collaborators

AstraZeneca

Investigators

  • Study Director: Pam Griffin, MD, MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 9, 2014

Last Update Submitted That Met QC Criteria

July 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-ID-MEDI-557-1089
  • D3150L00001 (Other Identifier: AstraZeneca AB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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