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Regular vs prn nebulized treatment in wheeze preschool children
A Papi1, G Nicolini2, E Baraldi3
1Department of Respiratory Diseases, Research Center on Asthma and COPD, University of Ferrara, Ferrara, Italy.
Insights
Regular inhaled glucocorticoids effectively treat frequent wheezing in preschoolers. A combination inhaler may be an alternative, but requires more research for preschool children with wheezing.
Area of Science:
- Pediatric Pulmonology
- Respiratory Medicine
- Clinical Trials
Background:
- International guidelines advocate regular inhaled glucocorticoids for children with frequent wheezing.
- Current practice often involves as-needed (prn) bronchodilator use, alone or with glucocorticoids.
- The efficacy of different treatment strategies for preschool wheezing requires further investigation.
Purpose of the Study:
- To compare the effectiveness of regular nebulized glucocorticoids plus prn bronchodilator against prn bronchodilator alone.
- To evaluate a prn nebulized bronchodilator/glucocorticoid combination versus prn bronchodilator alone.
- To determine optimal treatment for preschool children experiencing frequent wheeze.
Main Methods:
- A double-blind, randomized, parallel-group trial involving 276 children aged 1-4 years with frequent wheeze.
- Three treatment arms: regular beclomethasone with prn salbutamol, prn beclomethasone/salbutamol combination, and prn salbutamol alone.
- Primary outcome: percentage of symptom-free days over a 3-month treatment period.
Main Results:
- Regular beclomethasone significantly increased symptom-free days compared to prn salbutamol (69.6% vs. 61.0%, P=0.034).
- The prn bronchodilator/glucocorticoid combination did not show a significant increase in symptom-free days compared to prn salbutamol (64.9%).
- Treatment effects were consistent across children with and without risk factors for persistent asthma.
Conclusions:
- Regular inhaled glucocorticoid therapy is the most effective treatment for frequent wheezing in preschool children.
- A prn bronchodilator/glucocorticoid combination may represent a potential alternative, warranting further investigation.
- Evidence supports inhaled glucocorticoids as a primary treatment for preschool wheeze.
Background:
International guidelines recommend regular treatment with inhaled glucocorticoids for children with frequent wheezing; however, prn inhaled bronchodilator alone or in combination with glucocorticoid is also often used in practice. We aimed to evaluate whether regular nebulized glucocorticoid plus a prn bronchodilator or a prn nebulized bronchodilator/glucocorticoid combination is more effective than prn bronchodilator alone in preschool children with frequent wheeze.
Methods:
Double-blind, double-dummy, randomized, parallel-group trial. After a 2-week run-in period, 276 symptomatic children with frequent wheeze, aged 1-4 years, were randomly assigned to three groups for a 3-month nebulized treatment: (1) 400 microg beclomethasone bid plus 2500 microg salbutamol prn; (2) placebo bid plus 800 microg beclomethasone/1600 microg salbutamol combination prn; (3) placebo bid plus 2500 microg salbutamol prn. The percentage of symptom-free days was the primary outcome measure. Secondary outcomes included symptom scores, use of relief medication and exacerbation frequency.
Results:
As compared with prn salbutamol (61.0 +/- 24.83 [SD]), the percentage of symptom-free days was higher with regular beclomethasone (69.6%, SD 20.89; P = 0.034) but not with prn combination (64.9%, SD 24.74). Results were no different in children with or without risk factors for developing persistent asthma. The effect of prn combination was no different from that of regular beclomethasone on the primary and on several important secondary outcomes.
Conclusions:
Regular inhaled glucocorticoid is the most effective treatment for frequent wheezing in preschool children. However, prn bronchodilator/glucocorticoid combination might be an alternative option, but it requires further study.
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