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Early introduction of inhaled steroids in wheezing children presenting in primary care. A pilot study. EASE Study
1Department of Child Health, University of Aberdeen, Foresterhill, Aberdeen, UK.
Insights
Early inhaled corticosteroids (ICS) for childhood wheezing showed no significant lung function differences but improved quality of life. Further studies with 260 children are needed to confirm findings and assess long-term effects.
Area of Science:
- Pediatric Pulmonology
- Clinical Trial Design
- Respiratory Medicine
Background:
- Recurrent wheezing in children is common, prompting use of inhaled corticosteroids (ICS).
- Concerns exist regarding potential systemic adverse effects of early ICS initiation.
Purpose of the Study:
- To assess the feasibility and required sample size for a study on early ICS introduction.
- To evaluate benefits, adverse effects, and cost-effectiveness of early ICS use in children with recurrent wheezing.
Main Methods:
- A pragmatic randomized controlled trial involving 86 children (mean age 4.5 years) with recurrent wheezing.
- Children received either ICS (beclomethasone or budesonide) or beta2-agonist alone.
- Assessed lung function, respiratory symptoms, quality of life, growth, bone health, and healthcare costs over 6 months.
Main Results:
- A low dropout rate (8%) indicated protocol feasibility.
- No significant differences in lung function (FEV(1), T(ptef):T(e)) between groups at 6 months.
- Improvements in respiratory symptoms and quality of life were similar in both groups; bone turnover markers decreased in the ICS group (P<0.05), and healthcare costs were higher with ICS.
Conclusions:
- The study protocol is practical and acceptable for children with recurrent wheezing.
- A larger trial of 260 children is needed to confirm these findings.
- Early ICS use did not significantly impact lung function or growth but showed potential benefits in bone turnover markers.
Background:
Recurrent wheezing illness in childhood is a frequent reason for consultation in both primary and secondary care and whilst there is widespread support for the earlier introduction of inhaled corticosteroids (ICS) concerns remain about potential adverse systemic effects.
Objective:
We sought to identify the feasibility and size of study required to assess the benefits, adverse effects and cost-effectiveness of early introduction of ICS.
Methods:
We entered 86 children (mean age 4.5 years) with at least two consecutive wheezing episodes into a pragmatic randomized controlled trial. All children were already being prescribed beta2-agonist and those allocated to ICS were prescribed twice daily beclomethasone dipropionate 200 microg or budesonide 200 microg. At entry and 3 and 6 months age appropriate lung function (FEV(1), T(ptef):T(e)), respiratory symptoms, quality of life of children and carers, growth and sexual maturation, bone mass and bone turnover, and health care costs were assessed.
Results:
Drop out rate was 8% (7 of 86). No significant differences were found in FEV(1) or T(ptef):T(e) at 6 months. Respiratory symptoms and health-related quality of life of children and carers improved equally in both groups. No significant differences were found in growth rates or in bone mass. In the ICS group markers of bone turnover (Pyd:Cr) fell (271 vs 237 nmol/mmol) in contrast to a rise in those on beta(2) alone (255 vs 319 nmol/mmol) P < 0.05. Combined health care costs were higher in the ICS group.
Conclusions:
The low drop out rate provided evidence that the protocol was practical and acceptable. In order to confirm these results, and using the same study design, power estimates indicated that 260 children would need to be randomized.
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