Teper AM, Colom AJ, Kofman CD, Maffey AF, Vidaurreta SM, Bergada I. Pediatr Pulmonol. 2004;37:111–115
Purpose of the Study.
To evaluate the efficacy and safety of inhaled fluticasone propionate in children <2 years old with a history of recurrent wheezing and risk factors for asthma persisting into late childhood.
Subjects were 30 children, aged 7 to 24 months, with ≥3 episodes of wheeze responsive to bronchodilators and a family history of asthma, allergic rhinitis, or eczema.
In this double-blind study, subjects were randomized to receive either inhaled 50 μg of fluticasone twice daily, 125 μg of fluticasone twice daily, or placebo for 6 months. Medication was administered with a metered-dose inhaler using an Aerochamber and mask. Efficacy end points included number of wheezing episodes and number of days on which albuterol was required. Parents were trained to record these clinical symptoms and medication use on a chart. Subjects were seen monthly to assess proper use of the medication device and evaluate daily symptom records. Safety end points included measurement of growth, serum insulin-like growth factor–binding protein 3, cortisol, osteocalcin, and alkaline phosphatase. Clinical and safety outcomes were assessed before and after 6 months of treatment in both treatment and placebo groups.
Mean wheezing episodes were 6.0 ± 1.9, 1.9 ± 1.9, and 2.8 ± 1.2 per patient for placebo, 100-μg fluticasone, and 250-μg fluticasone groups, respectively. Mean days of albuterol use were 24.3 ± 1.3, 6.5 ± 0.8, and 9.1 ± 0.8 for placebo, 100-μg fluticasone, and 250-μg fluticasone groups, respectively. There was a significant reduction in wheezing episodes and albuterol use in the 2 fluticasone groups compared with placebo (P < .01), but there were no significant differences between the 2 fluticasone groups. After treatment, there were no significant differences observed in serum cortisol, bone metabolism markers (insulin-like growth factor–binding protein 3, alkaline phosphatase, and osteocalcin), or growth among the groups.
The authors concluded that inhaled fluticasone (50 or 125 μg) given twice daily over a 6-month period improved asthmatic symptoms and had no significant adverse effects on growth, bone metabolism, or serum cortisol in children aged 7 to 24 months.
This study suggests that the use of inhaled fluticasone in young children with recurrent wheezing and a positive family history is both safe and effective. In addition, the study is one of the few pieces of evidence that off-label use of inhaled steroid administered with a metered-dose inhaler with a holding chamber and mask is effective in chronic asthma in the very young (with the caveat of monthly review of technique). The safety findings of the study are limited, unfortunately, by its very small size. It is encouraging that the children studied, who would be predicted by the Tucson Children’s Respiratory Study data to be likely to develop persisting asthma, clearly respond to the therapy. The study does not address whether wheezy infants without risk factors for persisting asthma would respond to similar therapy. Larger studies including other subgroups of wheezy infants are needed to support these results.