PURPOSE OF THE STUDY.
To determine the effectiveness of inhaled beclomethasone dipropionate when used as a rescue treatment for symptoms in children with mild persistent asthma.
Children and adolescents aged 5 to 18 years with well-controlled mild persistent asthma were enrolled from 5 clinical centers in a 44-week, randomized, double-blind, placebo-controlled trial.
Participants who remained well controlled during the 4-week run-in period were stratified according to clinical center and age group and randomly assigned to 1 of 4 treatments: twice-daily beclomethasone with beclomethasone plus albuterol as rescue (combined group); twice-daily beclomethasone with placebo plus albuterol as rescue (daily beclomethasone group); twice-daily placebo with beclomethasone plus albuterol as rescue (rescue beclomethasone group); and twice-daily placebo with placebo plus albuterol as rescue (placebo group). Twice-daily treatment was 1 puff of beclomethasone (40 μg) or placebo, and rescue treatment for symptoms was 2 puffs of beclomethasone or placebo for every 2 puffs of albuterol (180 μg). The primary outcome, time to first exacerbation that required oral prednisone, and secondary outcome, linear growth, were analyzed according to intention to treat.
Of the 843 participants enrolled, 288 were assigned to a treatment group (combined, n = 71; daily, n = 72; rescue, n = 71; placebo, n = 74). Baseline characteristics were similar between included and excluded participants and among those in the 4 treatment groups. The frequency of exacerbations was lower in the combined (31% [95% confidence interval (CI): 21%–43%]; P = .07), daily (28% [95% CI: 18%–40%]; P = .03), and rescue (35% [95% CI: 24%–47%]; P = .07) groups compared with the placebo group (49% [95% CI: 37%–61%]). The frequency of treatment failure was 5.6% (95% CI: 1.6%–14%; P = .012) in the combined, 2.8% (95% CI: 0%–10%; P = .009) in the daily, and 8.5% (95% CI: 2%–15%; P = .024) in the rescue groups compared with 23% (95% CI: 14%–43%) in the placebo group. Compared with the placebo group, linear growth was 1.1 cm (SD: 0.3 cm) less in the combined and daily groups (P < .0001) but no different in the rescue group (P = .26).
Daily inhaled corticosteroids are the most effective treatment for children with mild persistent asthma. For children not taking a daily inhaled corticosteroid, inhaled beclomethasone used as a rescue medication with albuterol can lower the risk of exacerbations and treatment failures more effectively than albuterol alone but to a lesser extent than daily inhaled beclomethasone. Children with mild persistent asthma should not be treated with only rescue albuterol.
This study differs from previous trials of inhaled corticosteroids during asthma exacerbations in that it evaluated the benefit of adding a low-dose inhaled corticosteroid as rescue medication whenever albuterol was needed for treatment of symptoms. The results confirm the relative effectiveness of low-dose daily inhaled corticosteroids, which remain the first-line maintenance therapy for children with mild persistent asthma. Compared with rescue albuterol alone, the results also suggest a possible benefit without increased risk of growth impairment from inhaled corticosteroids added as rescue medication for children not taking a daily inhaled steroid. Among children with well-controlled mild persistent asthma, the ongoing need for and adherence to inhaled steroid controller therapy must be regularly assessed on an individual basis. These results might be useful when trying to balance the greater effectiveness and greater potential for adverse effects of daily inhaled steroid controller therapy in these patients.
- Copyright © 2011 by the American Academy of Pediatrics