An observational study in Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, sponsored by MedImmune LLC. Completed at 60 sites in 9 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-07-09.
Sponsored by MedImmune LLC · Observational
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 476 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Key Exclusion Criteria:
Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status
Time frame: Average of 2 years
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
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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