ocal anti-inflammatory treatment in the prevention of long-term airway morbidity following hospitalisation for respiratory syncytial virus (RSV) infection: clinical effectiveness and immunological correlates
Completed
- Conditions
- Respiratory syncytial virus lower respiratory tract infection (RSV LRTI)RespiratoryUnspecified acute lower respiratory infection
- Registration Number
- ISRCTN12352714
- Lead Sponsor
- Dutch Asthma Foundation (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
1. Infants under 13 months of age
2. Hospital admission for RSV LRTI
3. Positive immunofluorescence for RSV infection of epithelial cells in nasopharyngeal aspirates
Exclusion Criteria
1. Previous use of steroids
2. History of cardiac or pulmonary disease
3. Wheezing illness prior to RSV LRTI
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wheezing according to log registration from 3 until 15 months after hospitalisation for RSV LRTI
- Secondary Outcome Measures
Name Time Method 1. Wheezing according to log registration from hospitalisation until 15 months after hospitalisation<br>2. Coughing during follow up<br>3. Use of inhaled steroids (other than the intervention medication)<br>4. Use of bronchodilators<br>5. Days of hospitalisation<br>6. Respiratory Distress Assessment Instrument (RDAI) scores during hospitalisation<br>7. Local cytokine profiles (nasal aspirates) during the first three episodes of respiratory tract infections<br>8. Quality of life<br>9. Lung function (interrupter resistance measurement, RINT)<br>10. Physician-diagnosed asthma at the age of 6 years