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Low-dose inhaled budesonide once or twice daily for 27 months in children with mild asthma
G Jónasson1, K H Carlsen, C Jonasson
1Paediatric Section for Allergy and Pulmonology, Ullevål Hospital, Oslo, Norway.
Insights
Low-dose inhaled budesonide (BUD) is safe and effective for children with mild asthma, significantly reducing exercise-induced symptoms and improving lung function over 27 months.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Pharmacology
Background:
- Mild asthma in children requires effective long-term management strategies.
- Inhaled corticosteroids are a cornerstone of asthma therapy, but long-term effects need evaluation.
- Previous short-term studies suggested efficacy of low-dose inhaled budesonide (BUD).
Purpose of the Study:
- To evaluate the long-term clinical efficacy and safety of low-dose inhaled budesonide (BUD) in children with mild asthma.
- To compare once-daily versus twice-daily administration of BUD.
- To assess the dose-response relationship of inhaled BUD.
Main Methods:
- Extended follow-up (24 months) of a 12-week trial involving 122 children with mild asthma.
- Double-blind, randomized, parallel-group study comparing inhaled BUD (100 or 200 microg once daily, 100 microg twice daily) or placebo for 27 months.
- Regular exercise and methacholine challenges performed to assess bronchial hyperreactivity and lung function (FEV1, FEF25%, FEV50%).
Main Results:
- A significant dose-response effect favoring BUD 200 microg daily was observed for lung function parameters (FEV1, FEF25%, FEV50%) and reduced fall in FEV1 after exercise.
- Bronchial hyperreactivity to methacholine significantly decreased with BUD 200 microg daily compared to placebo.
- Growth rate was not significantly affected, with a minor exception in children aged 7-11 years at baseline after 12 months.
Conclusions:
- Low-dose inhaled budesonide (100 or 200 microg daily) is safe and effective for long-term management of mild asthma in children.
- Treatment protects against exercise-induced asthma and helps maintain near-normal lung function.
- The 200 microg daily dose demonstrated a superior dose-response effect compared to the 100 microg daily dose.
Abstract:
This study is an extended follow-up for 24 months of a 12-week trial to study the long-term clinical efficacy of low-dose inhaled budesonide (BUD) once or twice daily in children with mild asthma. A total of 122 children (mean age 9.7 years, girls/boys; 42/80) with mild asthma (FEV1 103.7% of predicted, reversibility in FEV1 3.5%, and fall in FEV1 after exercise 12.2%), not previously treated with inhaled steroids, were included in a double-blind, randomized, parallel-group study. The children were treated with inhaled BUD 100 or 200 microg administered via Turbuhaler once daily in the morning, 100 microg twice daily, or placebo for 27 months. Exercise and methacholine challenges were performed at 3-month intervals the first year and at 6-month intervals the second year, in a total of seven visits. A significant dose-response effect favoring BUD 200 microg daily (vs 100 microg daily) was found when comparing changes in FEV1, FEF25%, and FEV50%; the fall in FEV1 after an exercise test; and the effect on blood eosinophils. Bronchial hyperreactivity to methacholine decreased significantly on three visits in patients treated with BUD 200 microg daily compared to placebo. Growth rate was not significantly affected except in children aged 7-11 years at baseline after 12 months of treatment. In conclusion, 100 or 200 microg daily of inhaled BUD for 27 months is safe and effective in protecting against exercise-induced asthma and achieving nearly normal lung function. Baseline lung function was not significantly affected in this group of children with mild asthma.
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