Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca AB
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01455402
First received: October 12, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  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:

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

  Show 53 Study Locations
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 16, 2013