NCT01455402

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 476 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-10-20
• Last updated: 2014-07-09

Locations

60 sites across 9 countries: United States, Bulgaria, Canada, Czechia, France, Germany, Italy, Russia, Sweden