Efficacy of a short course of oral steroids for hospitalised preschool children with viral induced wheeze: a randomised double-blind placebo-controlled trial

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Prof Jonathan Grigg

ORCID ID

Contact details

Institute of Cell and Molecular Science
Queen Mary University London
Academic Unit of Paediatrics
4 Newark Street
London
E1 2AT
United Kingdom
+44 (0)20 7882 2206
j.grigg@qmul.ac.uk

EudraCT/CTIS number

2004-005124-40

IRAS number

ClinicalTrials.gov number

Protocol/serial number

Asthma UK Funded Project ID 04/039; EudraCT Number: 2004-005124-40

Scientific title

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)

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

Patient information sheet

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

Reason abandoned (if study stopped)

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 type(s)

Patient

Age group

Child

Lower age limit

10 Months

Upper age limit

60 Months

Sex

Both

Target number of participants

700

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

Countries of recruitment

England, United Kingdom

Study participating centre

Institute of Cell and Molecular Science
London
E1 2AT
United Kingdom

Organisation

Asthma UK

Sponsor details

Providence House
Providence Place
London
N1 0NT
United Kingdom
+44 (0)20 7226 2260
pmajor@asthma.org.uk

Sponsor type

Charity

Website

http://asthma.org.uk/

ROR

https://ror.org/03z7xev21

Funder type

Charity

Funder name

Asthma UK (Project ID 04/039)

Alternative name(s)

Asthma UK, Asthma + Lung UK

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs