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

Purpose

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.

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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Heart Failure

U.S. FDA Resources

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:

Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status [ Time Frame: Average of 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status [ Time Frame: Average of 2 years ] [ Designated as safety issue: No ]
Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths [ Time Frame: Average of 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Incidence of RSV-associated secondary bacterial pneumonia events [ Time Frame: Average of 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

serum, whole blood, plasma, nasal swab, sputum

Enrollment:	455
Study Start Date:	October 2011
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455402

Hide Study Locations

Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, Arkansas
Research Site
Fort Smith, Arkansas, United States, 72901
United States, Georgia
Research Site
Marietta, Georgia, United States, 30060
United States, Iowa
Research Site
Council Bluffs, Iowa, United States, 51503
United States, Nevada
Research Site
Reno, Nevada, United States, 89502
United States, New York
VA Western New York Healthcare System (VISN02)
Buffalo, New York, United States, 14215-1199
Research Site
Mineola, New York, United States, 11501
Rochester General Hospital
Rochester, New York, United States, 14621
United States, Ohio
Research Site
Chardon, Ohio, United States, 44024
United States, Pennsylvania
Research Site
Beaver, Pennsylvania, United States, 15009
Research Site
Jefferson Hills, Pennsylvania, United States, 15025
Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 35294
United States, Texas
Research Site
Houston, Texas, United States, 77030
Research Site
Kingwood, Texas, United States, 77339
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53295
Bulgaria
Research Site
Pleven, Bulgaria, 5800
Research Site
Razgrad, Bulgaria, 7200
Research Site
Sofia, Bulgaria, 1709
Research Site
Sofia, Bulgaria, 1233
Research Site
Sofia, Bulgaria, 1431
Research Site
Sofia, Bulgaria
Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8N 4A6
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4J 1C5
Research Site
Montreal, Quebec, Canada
Research Site
St-Romuald, Quebec, Canada, G6W 5M6
Canada
Research Site
Quebec, Canada, G1G 3Z4
Czech Republic
Research Site
Jindrichuv Hradec, 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
France
Research Site
Lyon Cedex 04, France
Research Site
Nantes Cedex 1, France, 44093
Germany
Research Site
Berlin, Germany, 10367
Research Site
Berlin, Germany, 12203
Research Site
Leipzig, Germany, 04207
Research Site
Leipzig, Germany, 04275
Research Site
Mannheim, Germany, 68165
Italy
Research Site
Ferrara, FE, Italy, 44121
Research Site
Genova, GE, Italy, 16132
Research Site
Pisa, PI, Italy, 56124
Research Site
Parma, PR, Italy, 43125
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Novosibirsk, Russian Federation
Sweden
Research Site
Goteborg, Sweden
Research Site
Linkoping, Sweden
Research Site
Lund, Sweden
Research Site
Uppsala, Sweden

Sponsors and Collaborators

MedImmune LLC

AstraZeneca AB

Investigators

Study Director:

Pam Griffin, MD

MedImmune LLC

More Information

No publications provided

Responsible Party:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT01455402 History of Changes
Other Study ID Numbers:	CD-ID-MEDI-557-1089, D3150L00001
Study First Received:	October 12, 2011
Last Updated:	May 1, 2013
Health Authority:	Bulgaria: Ethics committee Bulgaria: Competent Authority Canada: Ethics Committee Czech Republic: Ethics Committee France: Ethics Committee France: Data Privacy Board France: Competent Authority Germany: Ethics Committee Italy: Ethics Committee Russia: Ethics Committee Sweden: Ethics Committee United States: Institutional Review Board

Keywords provided by MedImmune LLC:

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

Additional relevant MeSH terms:

Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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