Clinical trial NCT01455402: An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
Keywords: Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Observational
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2011-10-20
Enrollment: 476
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
timeFrame: Average of 2 years
Secondary outcomes:
measure: All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status
timeFrame: Average of 2 years
measure: Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths
timeFrame: Average of 2 years
measure: Healthcare utilization for RSV-associated and all-cause medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status
timeFrame: Average of 2 years
measure: Incidence of RSV-associated secondary bacterial pneumonia events
timeFrame: Average of 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Fort Smith
country: United States
facility: Research Site
state: Arkansas
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Bay Pines
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Council Bluffs
country: United States
facility: Research Site
state: Iowa
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Mineola
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Chardon
country: United States
facility: Research Site
state: Ohio
city: Beaver
country: United States
facility: Research Site
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Kingwood
country: United States
facility: Research Site
state: Texas
city: Marshfield
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Pleven
country: Bulgaria
facility: Research Site
city: Razgrad
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Saint-Romuald
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Jindrichuv Hradec III
country: Czech Republic
facility: Research Site
city: Kyjov
country: Czech Republic
facility: Research Site
city: Liberec 1
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Rokycany
country: Czech Republic
facility: Research Site
city: Lyon Cedex 4
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Toulouse Cedex 4
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Ferrara
country: Italy
facility: Research Site
state: FE
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Genova
country: Italy
facility: Research Site
state: GE
city: Pisa
country: Italy
facility: Research Site
state: PI
city: Parma
country: Italy
facility: Research Site
state: PR
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: Pam Griffin, MD
role: STUDY_DIRECTOR
References: