Efficacy of a short course of oral steroids for hospitalised preschool children with viral induced wheeze: a randomised double-blind placebo-controlled trial
| ISRCTN | ISRCTN58363576 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58363576 |
| Clinical Trials Information System (CTIS) | 2004-005124-40 |
| Protocol serial number | Asthma UK Funded Project ID 04/039; EudraCT Number: 2004-005124-40 |
| Sponsor | Asthma UK |
| Funder | Asthma UK (Project ID 04/039) |
- Submission date
- 20/06/2007
- Registration date
- 06/07/2007
- Last edited
- 04/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jonathan Grigg
Scientific
Scientific
Institute of Cell and Molecular Science
Queen Mary University London
Academic Unit of Paediatrics
4 Newark Street
London
E1 2AT
United Kingdom
| Phone | +44 (0)20 7882 2206 |
|---|---|
| j.grigg@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-centre, three-hospital, randomised, double-blind placebo-controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TWICS (Treatment of Wheeze In Children with Steroids) |
| Study objectives | The outcome for preschool children (10 months to 60 months) admitted to the hospital with an attack of wheeze triggered by clinical viral infection (preschool viral wheeze) and treated with oral steroids will be no different than those children treated with placebo (primary null hypothesis). Secondary (null) hypotheses are that compared with oral placebo, treatment of hospitalised children with preschool viral wheeze with oral prednisolone will not: 1. Reduce the severity of respiratory distress at 4, 12, and 24 hours 2. Reduce the total severity of the attack, or the total amount of inhaled bronchodilators 3. Reduce the risk of significant hypoxia or re-admission within 4 weeks |
| Ethics approval(s) | 1. Fife and Forth Valley Local Research Ethics Committee (MREC ref: 05/S0501/7) 2. Leicestershire Local Research Ethics Committee Two (LREC ref: 05/Q2502/19) 3. Medicines and Healthcare products Regulatory Agency (MHRA) (CTA Number 23071/0001/001-0001) |
| Health condition(s) or problem(s) studied | Preschool wheeze: In children between 1 and 5 years the phenotype of 'asthma' is characterised by transient episodes of wheeze triggered by viral colds with no or few interval symptoms |
| Intervention | By double-blind, stratified (by centre) randomisation, children will receive either oral corticosteroids for 5 days or placebo along with inhaled bronchodilator therapy (frequency and mode of delivery device decided by the clinician). The dose of the oral corticosteroid, prednisolone will be 20 mg for 2 to 5 year olds and 10 mg for children under age of 2 years. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure(s) |
Length of stay in hospital, i.e. time from randomisation to discharge from the hospital which will be assessed in two ways: first when the child was felt fit to be discharged by a clinician and second when child was discharged home. |
| Key secondary outcome measure(s) |
1. Median symptom score (Preschool Respiratory Assessment Measure [PRAM] score) and parental symptom score (mean 7 day) |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Months |
| Upper age limit | 60 Months |
| Sex | All |
| Target sample size at registration | 700 |
| Key inclusion criteria | 1. Children aged 10 months to 60 months 2. Preceding history of a viral illness with upper respiratory tract symptoms/signs associated with an acute episode of physician diagnosed wheeze (preschool viral wheeze) 3. Who need admission to the hospital |
| Key exclusion criteria | 1. Children < 10 months and > 60 months age 2. Fluid resuscitation (more than or equal to 20 ml/kg) 3. Bacterial sepsis (e.g. bacterial pneumonia, meningitis) 4. Cystic fibrosis, bronchiectasis and children with upper respiratory tract structural abnormality 5. Children on home oxygen 6. Diagnosis of immune deficiency 7. History of chronic persistent wheeze with no evidence of a discrete deterioration in association with a clinical cold 8. Active chicken pox 9. Children admitted for social reasons |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Cell and Molecular Science
London
E1 2AT
United Kingdom
E1 2AT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 22/01/2009 | Yes | No |
