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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Publication citations
-
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.