Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart FailureCD-1089NCT01455402
An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF
An observational study of Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, run by MedImmune LLC at 60 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- How many people
- 476 participants
- Where
- 60 sitesin 9 countries
- Study dates
- Jul 2010to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Participation in another clinical study involving the use of investigational product
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
United States21 sites
Research Site
Bay Pines, Florida
Research Site
Beaver, Pennsylvania, 15009
Research Site
Birmingham, Alabama, 35294
Research Site
Buffalo, New York, 14215-1199
Research Site
Chardon, Ohio, 44024
Research Site
Council Bluffs, Iowa, 51503
Research Site
Denver, Colorado
Research Site
Fort Smith, Arkansas, 72901
Research Site
Houston, Texas, 77030
Research Site
Jefferson Hills, Pennsylvania, 15025
Research Site
Kingwood, Texas, 77339
Research Site
Marietta, Georgia, 30060
Research Site
Marshfield, Wisconsin
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin, 53295
Research Site
Mineola, New York, 11501
Research Site
Minneapolis, Minnesota
Research Site
Nashville, Tennessee, 35294
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Reno, Nevada, 89502
Research Site
Rochester, New York, 14621
Canada9 sites
Research Site
Edmonton, Alberta
Research Site
Hamilton, Ontario, L8N 4A6
Research Site
London, Ontario
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Montreal, Quebec
Research Site
Québec, Quebec, G1G 3Z4
Research Site
Saint Romuald, Quebec, G6W 5M6
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Bulgaria6 sites
Research Site
Pleven, Pleven, 5800
Research Site
Razgrad, Razgrad, 7200
Research Site
Sofia, Sofia, 1233
Research Site
Sofia, Sofia, 1431
Research Site
Sofia, Sofia, 1709
Research Site
Sofia, Sofia
Czechia5 sites
Research Site
Jindrichuv Hradec III, 377 01
Research Site
Kyjov, 697 01
Research Site
Liberec, 460 63
Research Site
Ostrava, 728 80
Research Site
Rokycany, 337 22
Germany5 sites
Research Site
Berlin, 10367
Research Site
Berlin, 12203
Research Site
Leipzig, 04207
Research Site
Leipzig, 04275
Research Site
Mannheim, 68165
Italy5 sites
Research Site
Ferrara, FE, 44121
Research Site
Florence, FI
Research Site
Genova, GE, 16132
Research Site
Parma, PR, 43125
Research Site
Pisa, PI, 56124
Sweden4 sites
Research Site
Gothenburg
Research Site
Linköping
Research Site
Lund
Research Site
Uppsala
France3 sites
Research Site
Lyon, France
Research Site
Nantes, 44093
Research Site
Toulouse, France
About this study
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)
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- Keywords
- Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Observational
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
Measured: Average of 2 years
Secondary outcomes (4)
All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status
Measured: Average of 2 years
Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths
Measured: Average of 2 years
Healthcare utilization for RSV-associated and all-cause medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status
Measured: Average of 2 years
Incidence of RSV-associated secondary bacterial pneumonia events
Measured: Average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJul 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Pam Griffin, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455402
- Sponsor's protocol ID
- CD-ID-MEDI-557-1089
- Other IDs
- D3150L00001
- Acronym
- CD-1089
- Status last verified
- Jul 2014
- First submitted
- 12 Oct 2011
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01455402
- Acronym / sponsor ID
- CD-1089 / CD-ID-MEDI-557-1089
- Conditions
- Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- Keywords
- Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Jul 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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 (1 listed)
- Participation in another clinical study involving the use of investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
Time frame: Average of 2 years
4 secondary outcomes
All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status
Time frame: 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
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
Incidence of RSV-associated secondary bacterial pneumonia events
Time frame: Average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pam Griffin, MD study director
MedImmune LLC
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, run by MedImmune LLC at 60 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Bulgaria, Czechia, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status (time frame: Average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.