Condition category
Respiratory
Date applied
02/09/2005
Date assigned
14/09/2005
Last edited
03/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rsv.umcutrecht.nl

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

http://www.astmafonds.nl

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

  1. 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.

  2. 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.

Additional files

Editorial Notes