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)
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| City: |
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Fort Smith |
| State: |
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Arkansas |
| Zip Code: |
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72901 |
| Conditions: |
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Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01455402 |
| Primary Contact: |
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Study Director
Pam Griffin, MD
MedImmune LLC
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| Backup Contact: |
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N/A |
| Location Contact: |
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Fort Smith, Arkansas 72901
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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