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

NCT ID: NCT01455402

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

476 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Exclusion Criteria

\- Participation in another clinical study involving the use of investigational product
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pam Griffin, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

Novosibirsk, , Russia

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Gothenburg, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Uppsala, , Sweden

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Leipzig, , Germany

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Mannheim, , Germany

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Ferrara, FE, Italy

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Florence, FI, Italy

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Genova, GE, Italy

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Pisa, PI, Italy

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Parma, PR, Italy

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Moscow, , Russia

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Birmingham, Alabama, United States

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Fort Smith, Arkansas, United States

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Denver, Colorado, United States

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Bay Pines, Florida, United States

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Miami, Florida, United States

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Marietta, Georgia, United States

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Council Bluffs, Iowa, United States

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Minneapolis, Minnesota, United States

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Reno, Nevada, United States

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Buffalo, New York, United States

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Mineola, New York, United States

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Rochester, New York, United States

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Chardon, Ohio, United States

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Beaver, Pennsylvania, United States

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Jefferson Hills, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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Marshfield, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Pleven, Pleven, Bulgaria

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Razgrad, Razgrad, Bulgaria

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Sofia, Sofia, Bulgaria

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Sofia, Sofia, Bulgaria

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Sofia, Sofia, Bulgaria

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Sofia, Sofia, Bulgaria

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Jindrichuv Hradec III, , Czechia

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Kyjov, , Czechia

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Liberec, , Czechia

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Ostrava, , Czechia

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Rokycany, , Czechia

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Lyon, France, France

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Toulouse, France, France

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Nantes, , France

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Berlin, , Germany

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Berlin, , Germany

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Leipzig, , Germany

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Countries

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United States Bulgaria Canada Czechia France Germany Italy Russia Sweden

Other Identifiers

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D3150L00001

Identifier Type: OTHER

Identifier Source: secondary_id

CD-ID-MEDI-557-1089

Identifier Type: -

Identifier Source: org_study_id

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