Study identifier:CD-ID-MEDI-557-1089
ClinicalTrials.gov identifier:NCT01455402
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
N/A
Yes
-
All
476
Observational
50 Years +
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jan 2017 by MedImmune, LLC
MedImmune, LLC
AstraZeneca AB
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.
Location
Location
Fort Smith, AR, United States, 72901
Location
Rochester, NY, United States, 14621
Location
Montreal, QC, Canada, H4J 1C5
Location
Quebec, QC, Canada, G1G 3Z4
Location
Hamilton, ON, Canada, L8N 4A6
Location
Pisa, PI, Italy, 56124
Location
Genova, GE, Italy, 16132
Location
Ferrara, FE, Italy, 44121
Arms | Assigned Interventions |
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