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One year treatment with salmeterol compared with beclomethasone in children with asthma. The Dutch Paediatric Asthma
A A Verberne1, C Frost, R J Roorda
1Department of Pediatrics, Erasmus University, Rotterdam, The Netherlands.
Insights
Beclomethasone improved lung function and asthma symptoms in children more than salmeterol. Salmeterol monotherapy is not recommended for pediatric asthma due to increased exacerbations.
Area of Science:
- Pediatric Pulmonology
- Asthma Management
- Pharmacotherapy
Background:
- Mild to moderate asthma in children requires effective treatment.
- Long-acting beta-agonists (LABAs) and inhaled corticosteroids (ICS) are common asthma medications.
- The comparative efficacy of salmeterol (LABA) and beclomethasone (ICS) in pediatric asthma is not fully established.
Purpose of the Study:
- To compare the effects of salmeterol and beclomethasone on lung function and symptoms in children with mild to moderate asthma.
- To evaluate the safety and efficacy of salmeterol monotherapy versus beclomethasone monotherapy in pediatric asthma.
Main Methods:
- A double-blind, parallel study randomized 67 children with mild to moderate asthma to receive either salmeterol 50 mcg b.i.d. or beclomethasone 200 mcg b.i.d.
- Participants were not on inhaled corticosteroids prior to the study.
- Outcomes assessed included lung function (FEV1, PD20 methacholine), symptoms (PEF, symptom scores), exacerbations, and growth over one year.
Main Results:
- Beclomethasone significantly increased FEV1, while salmeterol showed a small reduction.
- Beclomethasone improved airway hyperresponsiveness (PD20 methacholine) more than salmeterol.
- Asthma exacerbations and withdrawals due to exacerbations were significantly higher in the salmeterol group.
- Growth was significantly slower in the beclomethasone group compared to the salmeterol group.
Conclusions:
- Moderate-dose beclomethasone is superior to salmeterol in improving lung function and symptoms in children with mild to moderate asthma.
- Salmeterol should not be used as monotherapy in pediatric asthma due to increased exacerbation risk.
- While beclomethasone impacted growth, its overall efficacy in asthma control is greater than salmeterol monotherapy.
Abstract:
The aim of this study was to compare the effects of salmeterol and beclomethasone on lung function and symptoms in children with mild to moderate asthma. Sixty-seven children not treated with inhaled corticosteroids were randomized in a double-blind parallel study either to salmeterol 50 micrograms b.i.d. or beclomethasone 200 micrograms b.i.d. After one year, FEV1 significantly increased in the beclomethasone group, whereas in the salmeterol group there was a small reduction. Differences between groups were 14.2% predicted (p < 0.0001) and 7.0% predicted (p = 0.007) for pre- and postbronchodilator FEV1 values, respectively. PD20 methacholine decreased by 0.73 DD (p = 0.05) in the salmeterol group and increased by 2.02 DD (p < 0.0001) in the beclomethasone group. Morning and evening PEF and symptom scores improved in both groups, although more in the beclomethasone group. Asthma exacerbations, for which prednisolone was needed, were more frequent in the salmeterol group (17 versus two), as were the number of withdrawals due to exacerbations (six versus one). However, growth was significantly slower in the beclomethasone group (-0.28 SDS) compared with that in the salmeterol group (-0.03 SDS) (p = 0.001). We conclude that treatment with a moderate dose of beclomethasone is superior to salmeterol in children with mild to moderate asthma and recommend that salmeterol should not be used as monotherapy.