A COMPARISON OF BECLOMETHASONE, SALMETEROL, AND PLACEBO IN CHILDREN WITH ASTHMA

Background An inhaled glucocorticoid is currently the medication of ch oice for long-term control of persistent asthma in children. The role of long-acting beta(2)-adrenergic-receptor agonists, such as salmetero l, needs to be defined. Methods We conducted a randomized, double-blin d, placebo-controlled, parallel-group, one-year study of 241 children (mean [+/-SD] age, 9.3+/-2.4 years) with clinically stable asthma and less than one month of prior glucocorticoid use. We compared inhaled b eclomethasone dipropionate (200 mu g twice daily) with salmeterol xina foate (50 mu g twice daily) and placebo (lactose). The primary outcome measure, airway responsiveness (as assessed with a methacholine chall enge), was evaluated before treatment; after 3, 6, 9, and 12 months of treatment (12 and 36 hours after study medications had been withheld) ; and 2 weeks after the end of treatment, Spirometry, symptoms, use of rescue medication (200 mu g of albuterol inhaled as needed), and adve rse effects were also assessed. Results During months 1 through 12 ove rall, beclomethasone was associated with significantly less airway hyp erresponsiveness than salmeterol (P=0.003) or placebo (P<0.001). This effect was lost two weeks after treatment had been stopped. As compare d with placebo, beclomethasone was associated with less variability be tween morning and evening in the peak expiratory flow (P=0.002), as wa s salmeterol (P=0.02). Beclomethasone was also associated with a reduc ed need for albuterol as rescue therapy (P<0.001) and fewer withdrawal s because of asthma exacerbations (P=0.03), but salmeterol was not (P= 0.09 and P=0.55, respectively). During months 1 through 12, linear gro wth was 3.96 cm in the children receiving beclomethasone, as compared with 5.40 cm in the salmeterol group (P=0.004) and 5.04 cm in the plac ebo group (P=0.018). Height was not measured after treatment ended. Co nclusions Beclomethasone was effective in reducing airway hyperrespons iveness and in controlling symptoms of asthma, but it was associated w ith decreased linear growth. Salmeterol was not as effective as beclom ethasone in reducing airway hyperresponsiveness or in controlling symp toms; however, it was an effective bronchodilator and was not associat ed with rebound airway hyperresponsiveness, masking of symptoms, or ad verse effects. (C) 1997, Massachusetts Medical Society.