Summary Background Daily inhaled corticosteroids are an effective treatment for mild persistent asthma, but some children have exacerbations even with good day-to-day control, and many discontinue treatment after becoming asymptomatic. We assessed the effectiveness of an inhaled corticosteroid (beclomethasone dipropionate) used as rescue treatment. Methods In this 44-week, randomised, double-blind, placebo-controlled trial we enrolled children and adolescents with mild persistent asthma aged 5–18 years from five clinical centres in the USA. A computer-generated randomisation sequence, stratified by clinical centre and age group, was used to randomly assign participants to one of four treatment groups: 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 beclomethasone treatment was one puff of beclomethasone (40 µg per puff) or placebo given in the morning and evening. Rescue beclomethasone treatment was two puffs of beclomethasone or placebo for each two puffs of albuterol (180 µg) needed for symptom relief. The primary outcome was time to first exacerbation that required oral corticosteroids. A secondary outcome measured linear growth. Analysis was by intention to treat. This study is registered with clinicaltrials.gov, number NCT00394329. Results 843 children and adolescents were enrolled into this trial, of whom 288 were assigned to one of four treatment groups; combined (n=71), daily beclomethasone (n=72), rescue beclomethasone (n=71), and placebo (n=74)—555 individuals were excluded during the run-in, according to predefined criteria. Compared with the placebo group (49%, 95% CI 37–61), the frequency of exacerbations was lower in the daily (28%, 18–40, p=0·03), combined (31%, 21–43, p=0·07), and rescue (35%, 24–47, p=0·07) groups. Frequency of treatment failure was 23% (95% CI 14–43) in the placebo group, compared with 5·6% (1·6–14) in the combined (p=0·012), 2·8% (0–10) in the daily (p=0·009), and 8·5% (2–15) in the rescue (p=0·024) groups. Compared with the placebo group, linear growth was 1·1 cm (SD 0·3) less in the combined and daily arms (p<0·0001), but not the rescue group (p=0·26). Only two individuals had severe adverse events; one in the daily beclomethasone group had viral meningitis and one in the combined group had bronchitis. Interpretation Children with mild persistent asthma should not be treated with rescue albuterol alone and the most effective treatment to prevent exacerbations is daily inhaled corticosteroids. Inhaled corticosteroids as rescue medication with albuterol might be an effective step-down strategy for children with well controlled, mild asthma because it is more effective at reducing exacerbations than is use of rescue albuterol alone. Use of daily inhaled...

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Background Acute wheezing illnesses in preschoolers need better management strategies to reduce morbidity. Objectives To examine the effectiveness of episodic use of an inhaled corticosteroid and a leukotriene receptor antagonist in preschoolers with intermittent wheezing. Methods In a randomized, double-blind placebo-controlled twelve-month trial, 238 children aged 12-59 months with moderate-severe intermittent wheezing received 7-days of either budesonide inhalation suspension (1mg twice daily), montelukast (4mg daily), or placebos in addition to albuterol with each identified respiratory tract illness. Proportion of episode-free days (EFDs) during the 12-month trial was the primary outcome. Results The three treatment groups did not differ in proportions of EFDs, with adjusted mean (95% CI) EFDs of 76% (70%, 81%) for budesonide, 73% (66%, 79%) for montelukast, and 74% (65%, 81%) for conventional therapy (p=0.66). The three groups did not differ in oral corticosteroid use, health care utilization, quality of life, or linear growth. However, during respiratory tract illnesses, budesonide and montelukast therapy led to modest reductions in trouble breathing [(38% (p=0.003) and 37% (p=0.003)] and interference with activity scores [32% (p=0.01) and 40% (p=0.001)], most evident in those with positive asthma predictive indices. Conclusions In preschool children with moderate-to-severe intermittent wheezing, episodic use of either budesonide or montelukast early in respiratory tract illnesses, when added to albuterol, did not increase the proportion of EFDs or decrease oral corticosteroid use over a twelve-month period. However, indicators of severity of acute illnesses were reduced, particularly in children with positive asthma predictive indices. Capsule Summary The episodic use of budesonide or montelukast in preschool children with moderate-to-severe intermittent wheezing does not increase the proportion of episode free days, but decreases symptom severity during acute respiratory tract illnesses.