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
EudraCT/CTIS number	2004-005124-40
Secondary identifying numbers	Asthma UK Funded Project ID 04/039; EudraCT Number: 2004-005124-40

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

Not provided at time of registration

Contact information

Prof Jonathan Grigg
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
Email	j.grigg@qmul.ac.uk

Study information

Study design	Two-centre, three-hospital, randomised, double-blind placebo-controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	TWICS (Treatment of Wheeze In Children with Steroids)
Study hypothesis	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)
Condition	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prednisolone
Primary outcome measure	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.
Secondary outcome measures	1. Median symptom score (Preschool Respiratory Assessment Measure [PRAM] score) and parental symptom score (mean 7 day) 2. Total use of inhaled bronchodilators during hospitalisation (from notes) and total for 7 days post discharge (from parental diary and clinical notes) 3. Complications: 3.1. Hypoxia 3.2. Pediatric Intensive Care Unit (PICU) admission 3.3. Readmission within 1 month and withdrawal from the study
Overall study start date	01/01/2005
Overall study end date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Months
Upper age limit	60 Months
Sex	Both
Target number of participants	700
Participant 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
Participant 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
Recruitment start date	01/01/2005
Recruitment end date	01/01/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Cell and Molecular Science

London
E1 2AT
United Kingdom

Sponsor information

Asthma UK
Charity

Providence House
Providence Place
London
N1 0NT
United Kingdom

Phone	+44 (0)20 7226 2260
Email	pmajor@asthma.org.uk
Website	http://asthma.org.uk/
"ROR"	https://ror.org/03z7xev21

Funders

Funder type

Charity

Asthma UK (Project ID 04/039)
Private sector organisation / Other non-profit organizations

Alternative name(s): Asthma UK, Asthma + Lung UK
Location: United Kingdom

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	22/01/2009		Yes	No