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 |
| Secondary identifying numbers | 3.2.03.22 |
- 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
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 |
|---|---|
| l.bont@umcutrecht.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Corticosteroids |
| Primary outcome measure | 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 study start date | 01/10/2004 |
| Completion date | 01/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 13 Months |
| Sex | Both |
| Target number of participants | 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
3508 AB
Netherlands
Sponsor information
Dutch Asthma Foundation (Netherlands)
Charity
Charity
Speelkamp 28
P.O. Box 5
Leusden
3830 AA
Netherlands
| Website | http://www.astmafonds.nl |
|---|---|
"ROR" |
https://ror.org/00ddgbf74 |
Funders
Funder type
Charity
Dutch Asthma Foundation (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
