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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
ISRCTN ISRCTN12352714
DOI 10.1186/ISRCTN12352714
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title 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
Acronym N/A
Serial number at source 3.2.03.22
Study hypothesis Inhaled corticosteroids during the first three months following admission for respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) prevent the occurrence and severity of long-term airway morbidity.
Lay summary
Ethics approval Added 03/03/2009: Ethics Review Committee of University Medical Center Utrecht approved on the 17th May 2005 (ref: 04-056)
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Respiratory syncytial virus lower respiratory tract infection (RSV LRTI)
Participants - 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
Participants - exclusion criteria 1. Previous use of steroids
2. History of cardiac or pulmonary disease
3. Wheezing illness prior to RSV LRTI
Anticipated start date 01/10/2004
Anticipated end date 01/10/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 250
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 during three months

Subgroup-analyses
1. Analyses of children with wheezing during primary infection versus those not wheezing
2. Analyses of children with a qualitative good inhalation technique versus those without a good technique
3. Analyses of children with different pharmacogenetic polymorphisms (NR3C1: rs6191; 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
Primary outcome measure(s) Wheezing according to log registration from 3 until 15 months after hospitalisation for RSV LRTI
Secondary outcome measure(s) 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
Sources of funding Dutch Asthma Foundation (Netherlands)
Trial website http://www.rsv.umcutrecht.nl
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19336497
Contact name Dr  L  Bont
  Address Department of Pediatrics
Wilhelmina Children's Hospital
University Medical Centre Utrecht
P.O. Box 85090
  City/town Utrecht
  Zip/Postcode 3508 AB
  Country Netherlands
  Tel +31 (0)30 250 4000
  Fax +31 (0)30 250 5349
  Email l.bont@umcutrecht.nl
Sponsor Dutch Asthma Foundation (Netherlands)
  Address Speelkamp 28
P.O. Box 5
  City/town Leusden
  Zip/Postcode 3830 AA
  Country Netherlands
  Sponsor website: http://www.astmafonds.nl
Date applied 02/09/2005
Last edited 09/04/2009
Date ISRCTN assigned 14/09/2005
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