PURPOSE OF THE STUDY.
The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing.
The study included preschool-aged children with a history of viral wheezing who were seen in 1 of 40 Italian pediatric clinics for an upper respiratory tract infection between October 2010 and March 2012. Children were between 1 and 5 years of age, had at least 1 episode of viral wheezing (physician diagnosed) in the preceding 12 months, and had no or minimal asthma-like symptoms between airway infections. Children were excluded if they had been on inhaled or oral corticosteroids in the month before the study or if they had other chronic lower airway disease (eg, cystic fibrosis, bronchopulmonary dysplasia).
The study was designed as a randomized, double-blind, placebo-controlled trial. Children in the study population were randomly given either beclomethasone 400 µg or placebo twice daily for 10 days when seen in the clinic for an upper respiratory tract infection. Medications were delivered by nebulizer. Patients were clinically evaluated by a pediatrician at the start and end of the treatment period, and the parents performed a subjective evaluation of symptoms and treatment efficacy. The primary end point was the incidence of pediatrician-diagnosed viral wheezing during the 10-day treatment period.
Of a total of 525 children enrolled in the study, 521 were visited at the end of the treatment period. Wheezing was diagnosed by the pediatricians in 47 children (9.0% [95% confidence interval: 6.7 to 11.3]) with no statistically significant differences between treatment groups; for beclomethasone versus placebo, the relative risk was 0.61 (95% CI: –0.35 to 1.08). The treatment was considered helpful by 63% of parents (64% in the beclomethasone group vs 61% in the placebo group). Collectively, 46% of children had infection-related symptoms at 10 days, with no differences between groups.
Inhaled corticosteroids were not effective in preventing recurrence of viral wheezing, nor were there benefits found in reducing the symptoms of respiratory tract infections.
Although this study does not show a statistical difference between the beclomethasone and placebo groups, there are several important caveats. In screening for this study, 1371 children were seen and 846 children were excluded, mostly for wheezing at the baseline visit and corticosteroid use in the previous month. Had these children been seen a day earlier without wheezing, or a couple weeks later when they were “off” steroids, they may have qualified for the study; in addition, considering they may well have had increased bronchial hyperresponsiveness compared with some of the children in the study, this action may have accentuated the differences between beclomethasone and placebo. Although the conclusion of the study stands, it is important to note the strong trend in favor of beclomethasone, with a relative risk of 0.61 and the upper end of the 95% CI just eclipsing unity at 1.08 (associated with a P value of .09). A final point is that the study did not document when the child first exhibited signs of a viral upper respiratory tract infection. If the average child was not seen until day 3 (or even later), this delay in corticosteroid therapy could also bias the results to show minimal differences. In this regard, a useful follow-up study would be to repeat the protocol but only allow entrance in the first 24 to 48 hours of an upper respiratory tract infection; this early intervention would mimic what we currently tell our parents to do.
- Copyright © 2014 by the American Academy of Pediatrics