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Completed

NCT Number: NCT01455402

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

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Key information

Conditions

Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure Cardiovascular Diseases Chronic Disease Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Pleven, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status

    Time frame: Average of 2 years

Secondary outcomes

  1. All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status

    Time frame: Average of 2 years

  2. Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths

    Time frame: Average of 2 years

  3. 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

  4. Incidence of RSV-associated secondary bacterial pneumonia events

    Time frame: Average of 2 years

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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)

Acronym: CD-1089

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 20, 2011
Registry last updated
Jul 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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