Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr L Bont
ORCID ID
Contact details
Department of Pediatrics
Wilhelmina Children's Hospital
University Medical Centre Utrecht
P.O. Box 85090
Utrecht
3508 AB
Netherlands
+31 (0)30 250 4000
l.bont@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3.2.03.22
Study information
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
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.
Ethics approval
Ethics Review Committee of University Medical Center Utrecht, 17/05/2005, ref: 04-056
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory syncytial virus lower respiratory tract infection (RSV LRTI)
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Corticosteroids
Primary outcome measures
Wheezing according to log registration from 3 until 15 months after hospitalisation for RSV LRTI
Secondary outcome measures
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
Overall trial start date
01/10/2004
Overall trial end date
01/10/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
250
Participant exclusion criteria
1. Previous use of steroids
2. History of cardiac or pulmonary disease
3. Wheezing illness prior to RSV LRTI
Recruitment start date
01/10/2004
Recruitment end date
01/10/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Pediatrics
Utrecht
3508 AB
Netherlands
Sponsor information
Organisation
Dutch Asthma Foundation (Netherlands)
Sponsor details
Speelkamp 28
P.O. Box 5
Leusden
3830 AA
Netherlands
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Dutch Asthma Foundation (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19336497
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24346594
Publication citations
-
Results
Ermers MJ, Rovers MM, van Woensel JB, Kimpen JL, Bont LJ, , The effect of high dose inhaled corticosteroids on wheeze in infants after respiratory syncytial virus infection: randomised double blind placebo controlled trial., BMJ, 2009, 338, b897.
-
Results
Zomer-Kooijker K, van der Ent CK, Ermers MJ, Rovers MM, Bont LJ, , Lack of long-term effects of high-dose inhaled beclomethasone for respiratory syncytial virus bronchiolitis: a randomized placebo-controlled trial., Pediatr. Infect. Dis. J., 2014, 33, 1, 19-23, doi: 10.1097/01.inf.0000437807.83845.d6.