RESCUE STUDY: BURDEN OF RSV An Observational Study to Assess Respiratory Syncytial Virus (RSV)-associated Illness in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
- Conditions
- COPD10006436
- Registration Number
- NL-OMON45338
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
- Age *40 years at recruitment.
- Smoking history of *10 pack years.
- COPD patients with an FEV1/FVC <0.7.
Exclusion Criteria
- Patients with a history of asthma, significant bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease.
- Patients taking immunosuppressive medications.
- Active cancer diagnosis.
- Long-term steroid therapy (*10 mg/day).
- Females of childbearing potential without an efficient contraception.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this prospective observational study is to determine<br /><br>the incidence of RSV acute respiratory infection or events leading to worsening<br /><br>cardiorespiratory status across multiple consecutive RSV. In addition, we will<br /><br>assess if and how the occurrence of an RSV virus infection affects the<br /><br>long-term outcome of COPD as reflected by rate of lung function decline, course<br /><br>of symptoms, and rate of COPD exacerbations during the follow-up of this study.</p><br>
- Secondary Outcome Measures
Name Time Method