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	https://doi.org/10.1186/ISRCTN12352714
Protocol serial number	3.2.03.22
Sponsor	Dutch Asthma Foundation (Netherlands)
Funder	Dutch Asthma Foundation (Netherlands)

Submission date: 02/09/2005
Registration date: 14/09/2005
Last edited: 03/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L Bont
Scientific

Department of Pediatrics
Wilhelmina Children's Hospital
University Medical Centre Utrecht
P.O. Box 85090
Utrecht
3508 AB
Netherlands

Phone	+31 (0)30 250 4000
Email	l.bont@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Ethics Review Committee of University Medical Center Utrecht, 17/05/2005, ref: 04-056
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Corticosteroids
Primary outcome measure(s)	Wheezing according to log registration from 3 until 15 months after hospitalisation for RSV LRTI
Key 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
Completion date	01/10/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	13 Months
Sex	All
Target sample size at registration	250
Key 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
Key exclusion criteria	1. Previous use of steroids 2. History of cardiac or pulmonary disease 3. Wheezing illness prior to RSV LRTI
Date of first enrolment	01/10/2004
Date of final enrolment	01/10/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Pediatrics

Utrecht
3508 AB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	31/03/2009		Yes	No
Results article	results	01/01/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes