A randomised controlled trial of oral prednisolone for viral-wheeze in pre-school children with stratification for serum level of Eosinophil Protein X (EPX)
| ISRCTN | ISRCTN78625210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78625210 |
| Secondary identifying numbers | AM2/01/008 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 13/03/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jonathan Grigg
Scientific
Scientific
University of Leicester
Leicester Royal Infirmary
P.O. Box 65
Leicester
LE2 7LX
United Kingdom
| Phone | +44 (0)116 252 5840 |
|---|---|
| jg33@leicester.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/1999 |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 18 Months |
| Upper age limit | 48 Months |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Children aged between 18 and 48 months of age presenting with viral-wheeze. |
| Key exclusion criteria | No exclusion criteria |
| Date of first enrolment | 01/03/1999 |
| Date of final enrolment | 28/02/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leicester
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Asthma National Research and Development Programme (UK)
No information available
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? |
|---|---|---|---|---|---|
| Abstract results | 01/11/2003 | No | No |
