Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
13/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Grigg

ORCID ID

Contact details

University of Leicester
Leicester Royal Infirmary
P.O. Box 65
Leicester
LE2 7LX
United Kingdom
+44 (0)116 252 5840
jg33@leicester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AM2/01/008

Study information

Scientific title

Acronym

Study hypothesis

This study will test the hypothesis that in preschool children with viral-wheeze, those with atopic pulmonary inflammation will respond to a short course of oral corticosteroids, whereas those with a structurally based vulnerability to wheeze will not.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Respiratory tract diseases: Asthma

Intervention

Children passing the inclusion criteria will be divided into two groups
a. Those with presenting serum EPX levels of greater than or equal to 25 ug/l
b. Those with EPX levels <25 ug/l.
At the next episode of viral wheeze children in both groups will receive either placebo or a short course of oral prednisolone.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisolone

Primary outcome measures

Outcome will be assessed by parental scoring of respiratory symptoms using a diary card.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/1999

Overall trial end date

28/02/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged between 18 and 48 months of age presenting with viral-wheeze.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/03/1999

Recruitment end date

28/02/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Asthma National Research and Development Programme (UK)

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=14602435

Publication citations

  1. Oommen A, Lambert PC, Grigg J, Efficacy of a short course of parent-initiated oral prednisolone for viral wheeze in children aged 1-5 years: randomised controlled trial., Lancet, 2003, 362, 9394, 1433-1438, doi: 10.1016/S0140-6736(03)14685-5.

Additional files

Editorial Notes