Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000305628
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of length of oral prednisolone in acute exacerbations of childhood asthma
Scientific title
Randomised controlled trial of length of oral prednisolone to reduce morbidity in acute exacerbations of childhood asthma
Universal Trial Number (UTN)
Trial acronym
LOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 393 0
Condition category
Condition code
Respiratory 465 465 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention= additional Oral Prednisolone for 2 days.
Intervention code [1] 301 0
Treatment: Drugs
Comparator / control treatment
Control group= additional placebo for 2 days ie study compares 3vs 5 days of oral prednisolone.
Control group
Placebo

Outcomes
Primary outcome [1] 526 0
Proportion of children without asthma symptoms as scored on the validated asthma diary cards
Timepoint [1] 526 0
On days 5, 7, 14, 21.
Secondary outcome [1] 1128 0
Carer/parent-QOL
Timepoint [1] 1128 0
Measured at days 1, 7, 14, 21, 28.
Secondary outcome [2] 1129 0
child-QOL
Timepoint [2] 1129 0
Measured at days 1, 7, 14, 21, 28.
Secondary outcome [3] 1130 0
CARIFS
Timepoint [3] 1130 0
Measured daily from baseline for 28 days.
Secondary outcome [4] 1131 0
Cough score and asthma score
Timepoint [4] 1131 0
Measured daily from baseline for 28 days.

Eligibility
Key inclusion criteria
Minimum age
2 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A black sticker obscures the next treatment group and is only removed after enrolment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children are randomised within strata of age (<6 years or >= 6 years) and site of enrolment. They are subsequently allocated to the next treatment regimen on a list, which was been previously generated, in random order, at a remote site (Queensland Institute of Medical Research). The method of randomisation was permutated block design by computer generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 520 0
Charities/Societies/Foundations
Name [1] 520 0
Asthma Foundation of Queensland
Country [1] 520 0
Australia
Funding source category [2] 521 0
Charities/Societies/Foundations
Name [2] 521 0
Royal Children's Hospital Foundation
Country [2] 521 0
Australia
Primary sponsor type
Hospital
Name
Royal Chidlren's Hospital
Address
Country
Australia
Secondary sponsor category [1] 424 0
Individual
Name [1] 424 0
Anne Chang
Address [1] 424 0
Country [1] 424 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35231 0
Address 35231 0
Country 35231 0
Phone 35231 0
Fax 35231 0
Email 35231 0
Contact person for public queries
Name 9490 0
Anne Chang
Address 9490 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston QLD 4029
Country 9490 0
Australia
Phone 9490 0
+61 7 36369149
Fax 9490 0
+61 7 36361958
Email 9490 0
[email protected]
Contact person for scientific queries
Name 418 0
Helen Petsky
Address 418 0
Department of Respiratory Medicine
Royal Children's Hospital
Herston QLD 4029
Country 418 0
Australia
Phone 418 0
+61 7 36361684
Fax 418 0
+61 7 36361958
Email 418 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.