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

July 8, 2014 updated by: MedImmune LLC

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
Time Frame: Average of 2 years
Average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status
Time Frame: Average of 2 years
Average of 2 years
Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths
Time Frame: Average of 2 years
Average of 2 years
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
Average of 2 years
Incidence of RSV-associated secondary bacterial pneumonia events
Time Frame: Average of 2 years
Average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pam Griffin, MD, MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CD-ID-MEDI-557-1089
  • D3150L00001 (Other Identifier: AstraZeneca AB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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