Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze (ICS@ADP)
The aim of the study is to investigate whether inhaled corticosteroids after a first hospital admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these complaints in children aged 1 to 4 years.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze|
- Number of unscheduled doctor visits for dyspnea and wheezing [ Time Frame: One and a half, 3, 6 and 9 months after discharge. ] [ Designated as safety issue: Yes ]
- PACQLQ scores and the use of additional asthma medication [ Time Frame: One and a half, 3, 6 and 9 months after discharge. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Beclomethasone
Beclometasone 100 ug b.i.d. by metered dose inhaler with spacer for 6 months
Other Name: Qvar
Placebo Comparator: Placebo
Placebo once a day by metered dose inhaler with spacer for 6 months
Other Name: Placebo
Symptoms of dyspnea and wheeze occur frequently in young children with a cumulative incidence of 33% before the age of 3 and up to 50% by the age of 6 years. Most wheezing episodes in preschool children are associated with viral upper respiratory tract infections (episodic viral wheeze). The majority of children with episodic viral wheeze have become asymptomatic by the age of 6 years. About one in three preschool children with recurrent wheeze continue to wheeze after the age of six years, and these children are usually diagnosed with asthma.
Two clinical phenotypes of recurrent wheezing in preschool children can be distinguished. Children with episodic viral wheeze only wheeze with viral upper respiratory tract infections and are symptom free in between episodes. A minority of children wheeze during upper respiratory tract infection and with other trigger factors (such as smoke, fog, exercise) and this is defined as multiple trigger wheeze.
Inhaled corticosteroids (ICS) have been shown to be effective in preschool children with multiple trigger wheeze, but the effect is smaller than that in older children. This justifies a more critical approach towards such therapy, for example by prescribing a trial of ICS for a period of 3 months and evaluating the effect afterwards. Little research has been performed on the effect of ICS in preschool children with episodic viral wheeze. A high dose of ICS (>1600 ug/d) during an acute episode of dyspnea and wheezing has been shown to be effective, but in a number of small clinical trials maintenance treatment with ICS did not have an effect on the number and severity of episodes of viral wheezing. Contradictory results have been published about the effect of ICS in infants and preschool children with Respiratory Syncytial Virus bronchiolitis. Some studies showed a reduction of wheezing episodes after RSV bronchiolitis in children treated with ICS, two other studies did not show any positive effect.
Prescribing ICS in preschool children can result in adverse effects such as a reduced height growth. Because of the lack of evidence of effect of ICS in episodic viral wheeze, guidelines advise a critical approach towards prescribing ICS in episodic viral wheeze.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962299
|Princess Amalia Children's Clinic|
|Zwolle, Overijssel, Netherlands, 8025 AB|
|Principal Investigator:||N Doornebal, MD||Princess Amalia Children's Clinic|
|Study Director:||J Bekhof, MD||Princess Amalia Children's Clinic|
|Study Director:||P LP Brand, MDPhD||Princess Amalia Children's Clinic|