Local anti-inflammatory treatment in the prevention of long-term airway morbidity following hospitalisation for respiratory syncytial virus (RSV) infection: clinical effectiveness and immunological correlates

Local anti-inflammatory treatment in the prevention of long-term airway morbidity following hospitalisation for respiratory syncytial virus (RSV) infection: clinical effectiveness and immunological correlates - a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12352714

Enrollment

250

Registered

2005-09-14

Start date

2004-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory syncytial virus lower respiratory tract infection (RSV LRTI) Respiratory Unspecified acute lower respiratory infection

Interventions

1. Intervention starts within 24 hours following positive immunofluorescence for RSV infection 2. Hydrofluoroalkane (HFA)-based beclomethasone dipropionate (Qvar, 3M) or placebo 3. 200 µg twice daily

NR3C1: SNPNR3C1

JUN: rs11688

FOS: rs7101

NFKB2: rs7897947

VDR: rs10735810

VDR: rs1544410

VDR: rs731236

IL13: rs20541

IL13: rs1800925

CRHR1: rs242941) (this information was added to this record as of the 12th June 2007) 4. Analyses of children with mechanical ventilation versus those without mechanical ventilation

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Previous use of steroids 2. History of cardiac or pulmonary disease 3. Wheezing illness prior to RSV LRTI

Design outcomes

Primary

Measure	Time frame
Wheezing according to log registration from 3 until 15 months after hospitalisation for RSV LRTI	—

Secondary

Measure	Time frame
1. Wheezing according to log registration from hospitalisation until 15 months after hospitalisation 2. Coughing during follow up 3. Use of inhaled steroids (other than the intervention medication) 4. Use of bronchodilators 5. Days of hospitalisation 6. Respiratory Distress Assessment Instrument (RDAI) scores during hospitalisation 7. Local cytokine profiles (nasal aspirates) during the first three episodes of respiratory tract infections 8. Quality of life 9. Lung function (interrupter resistance measurement, RINT) 10. Physician-diagnosed asthma at the age of 6 years	—

Measure

Time frame

1. Wheezing according to log registration from hospitalisation until 15 months after hospitalisation 2. Coughing during follow up 3. Use of inhaled steroids (other than the intervention medication) 4. Use of bronchodilators 5. Days of hospitalisation 6. Respiratory Distress Assessment Instrument (RDAI) scores during hospitalisation 7. Local cytokine profiles (nasal aspirates) during the first three episodes of respiratory tract infections 8. Quality of life 9. Lung function (interrupter resistance measurement, RINT) 10. Physician-diagnosed asthma at the age of 6 years

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026