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Trial registered on ANZCTR


Registration number
ACTRN12605000631606
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
12/10/2005
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of acute exacerbations of asthma in children with a doubling of the usual inhaled corticosteroid (ICS) dose.
Scientific title
A Multicentre Randomised Controlled Trial of Treatment of Acute Exacerbations of Asthma in Children with a Doubling of the Usual Inhaled Corticosteroid(ICS) Dose to identify efficacy of intervention.
Secondary ID [1] 192 0
FMS40267
Universal Trial Number (UTN)
Trial acronym
DICS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 759 0
Condition category
Condition code
Respiratory 835 835 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind, placebo-controlled, parallel, multi-centre trial. Children will be regularly on inhaled Fluticasone Propionate. Children will be randomised to receive either double their usual dose of inhaled corticosteroids or their usual dose of inhaled corticosteroid + placebo with intercurrent upper respiratory infections or exacerbations of their asthma for the following 12 months.

Children aged 6 years or older will be asked to perform spirometry at all visits. Peak flow measurements will also be recorded. Height and weight will be measured using standard equipment (Harpenden stadiometer or equivalent) that will be consistent for each centre at each visit.
Intervention code [1] 553 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1072 0
To determine whether doubling inhaled corticosteroids at the first sign of a cold or of asthma deterioration in children on preventive treatment with inhaled corticosteroids leads to a reduced need for oral steroid rescue or reduced risk of admission to hospital.
Timepoint [1] 1072 0
At the time of admission
Secondary outcome [1] 1989 0
Time for peak flow values and spirometry to return to baseline in children old enough to perform lung function
Timepoint [1] 1989 0
at the first sign of a cold or of asthma deterioration
Secondary outcome [2] 1990 0
School days missed in school aged children.
Timepoint [2] 1990 0
at the first sign of a cold or of asthma deterioration

Eligibility
Key inclusion criteria
Currently using 125mcg or greater of inhaled Cortico-steroid dailyExacerbation of asthma in past 12/12 requiring Oral Steroid
Minimum age
3 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with other respiratory diseases such as cystic fibrosis. Children with other significant medical conditions that may affect growth.

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)
The randomisation key is concealed and held at the Department Epidemiology and Preventative Medicine (DEPM), Monash Medical School, Melbourne. Central randomisation by phone/fax occurred after consent was obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We use stratified blocked randomisation of subjects to Active or Control groups using Stata (1,2); stratification was by site, sex, and age group, and blocks were used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 923 0
Charities/Societies/Foundations
Name [1] 923 0
Asthma Foundation Queensland
Address [1] 923 0
42 Costin Street, Fortitude Valley 4006
Country [1] 923 0
Australia
Primary sponsor type
Individual
Name
Asthma Foundation Queensland
Address
42 Costin Street, Fortitude Valley 4006
Country
Australia
Secondary sponsor category [1] 781 0
None
Name [1] 781 0
Infrastructure Funding from RCH Foundation
Address [1] 781 0
Country [1] 781 0
Australia
Secondary sponsor category [2] 291112 0
None
Name [2] 291112 0
Nil
Address [2] 291112 0
Nil
Country [2] 291112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2211 0
Royal Children's Hospital & Health Service District
Ethics committee address [1] 2211 0
Herston Rd
Herston 4029
Ethics committee country [1] 2211 0
Australia
Date submitted for ethics approval [1] 2211 0
16/09/2003
Approval date [1] 2211 0
29/10/2001
Ethics approval number [1] 2211 0
DICS Study
Ethics committee name [2] 2213 0
West Moreton Health Service District
Ethics committee address [2] 2213 0
Ethics committee country [2] 2213 0
Australia
Date submitted for ethics approval [2] 2213 0
Approval date [2] 2213 0
Ethics approval number [2] 2213 0
Ethics committee name [3] 2214 0
Gold Coast Health Service District
Ethics committee address [3] 2214 0
Ethics committee country [3] 2214 0
Australia
Date submitted for ethics approval [3] 2214 0
Approval date [3] 2214 0
Ethics approval number [3] 2214 0
Ethics committee name [4] 2215 0
Bayside Health Service District
Ethics committee address [4] 2215 0
Ethics committee country [4] 2215 0
Australia
Date submitted for ethics approval [4] 2215 0
Approval date [4] 2215 0
Ethics approval number [4] 2215 0
Ethics committee name [5] 2216 0
The Wesley Hospital
Ethics committee address [5] 2216 0
Ethics committee country [5] 2216 0
Australia
Date submitted for ethics approval [5] 2216 0
Approval date [5] 2216 0
Ethics approval number [5] 2216 0

Summary
Brief summary
To determine whether doubling inhaled corticosteroids at the first sign of a cold or of asthma deterioration in children on preventive treatment with inhaled corticosteroids leads to a reduced need for oral steroid rescue or reduced risk of admission to hospital.
To examine the effect of doubling the dose of inhaled corticosteroids at the first sign of a cold or asthma deterioration on the growth of children on preventive treatment for asthma.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36355 0
Prof Claire Wainwright
Address 36355 0
5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
501 Stanley St.
South Brisbane
Country 36355 0
Australia
Phone 36355 0
+617 30681111
Fax 36355 0
+30697159
Email 36355 0
Claire Wainwright
Contact person for public queries
Name 9742 0
Prof Claire Wainwright
Address 9742 0
5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
501 Stanley St.
South Brisbane
Country 9742 0
Australia
Phone 9742 0
+617 30681111
Fax 9742 0
+617 30697159
Email 9742 0
claire.wainwright@health.qld.gov.au
Contact person for scientific queries
Name 670 0
Prof Claire Wainwright
Address 670 0
5a Respiratory & Sleep Medicine
Lady Cilento Children's Hospital
501 Stanley St.
South Brisbane
Country 670 0
Australia
Phone 670 0
+617 30681111
Fax 670 0
+617 30697159
Email 670 0
claire.wainwright@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary