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Treatment of acute exacerbations of asthma in children with a doubling of the usual inhaled corticosteroid (ICS) dose.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000631606
Acronym
DICS Study
Enrollment
250
Registered
2005-10-12
Start date
2002-05-05
Completion date
2003-11-21
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 wil

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.

Sponsors

Asthma Foundation Queensland
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

Currently using 125mcg or greater of inhaled Cortico-steroid dailyExacerbation of asthma in past 12/12 requiring Oral Steroid

Exclusion criteria

Children with other respiratory diseases such as cystic fibrosis. Children with other significant medical conditions that may affect growth.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026