Addition of Salmeterol versus Doubling the Dose of Beclomethasone in Children with Asthma

Abstract

Studies in adults revealed that addition of salmeterol to a moderate dose of inhaled corticosteroid resulted in better symptom control and higher PEF compared with doubling the dose of inhaled corticosteroid. The aim of this three group study was to compare the effects of a moderate dose of beclomethasone, the same dose of beclomethasone with salmeterol, and a doubling dose of beclomethasone on lung function and symptoms in children with moderate asthma. A total of 177 children already treated with inhaled corticosteroids, were randomized in a double-blind parallel study either to salmeterol 50 microg twice daily (BDP400+salm), beclomethasone 200 microg twice daily (BDP800), or placebo (BDP400) in addition to beclomethasone 200 microg twice daily. No significant differences between groups were found in FEV1, PD20 methacholine, symptom scores, and exacerbation rates after 1 yr. Salmeterol resulted in slightly better PEF in the first months of treatment. FEV1, and PD20 methacholine significantly improved in all groups. After 1 yr mean changes in FEV1, percent predicted were 4.3% (95% CI 1.3; 7.2), 5.8% (95% CI 2.9; 8.7), and 4.3% (95% CI 2.1; 6.5) for BDP400+salm, BDP800, and BDP400, respectively. Changes in airway responsiveness were 0.60 (95% CI 0.05; 1.14), 1.30 (95% CI 0.73; 1. 87), and 0.80 (95% CI 0.33; 1.27) doubling doses. Growth was significantly slower in the BDP800 group. We conclude that no additional benefit was found of adding either salmeterol or more beclomethasone to a daily dose of 400 microg beclomethasone in this group of children with excellent compliance of medication.

Global strategy for asthma management and prevention: GINA executive summary

“…For all children, but particularly for those aged f5 yrs, combination therapy has been less well studied, and the addition of a long-acting b 2 -agonist may not be as effective as increasing the dose of inhaled glucocorticosteroids in reducing exacerbations [182,291,292]. However, the interpretation of some studies is problematic, as not all children received concurrent inhaled glucocorticosteroids [182,291].…”

Children with asthma on inhaled corticosteroids managed in general practice or by hospital paediatricians: is there a difference?

“…Verberne et al showed in a prospective randomised controlled study that children with moderate severe asthma did not benefit from doubling their dose of ICS, or from addition of a LABA to their ICS. 17 Some authors have even suggested a worsening of asthma control by treatment with the combination of an ICS and a LABA. Bisgaard found that the relative risk of an asthma exacerbation as well as the risk of hospitalisation for asthma was increased for children using additional LABA compared to regular maintenance therapy with ICS; 18 he concluded that the lack of evidence for the control of asthma exacerbations in children regularly using a LABA should bring into question its general use as add-on therapy.…”

Mortality in Asthma-Chronic Obstructive Pulmonary Disease Overlap in the United States

“…In children, the preferred option is to increase ICS to medium dose (see Box 3-6, p.44), 172 and in this age group, the effect may be similar to 173 or more effective 174,175 than adding LABA.…”