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Nebulized beclomethasone not effective at preventing recurrence of viral wheezing

Clinical Question:
In young children with a history of viral wheezing, is nebulized corticosteroid treatment effective to prevent another episode of wheeze during a subsequent respiratory tract infection?

Bottom Line:
In young children with a history of wheeze during respiratory infection, pre-emptive treatment with a nebulized steroid during a subsequent respiratory tract infection does not prevent a second episode of wheeze or decrease the duration of symptoms. Approximately two thirds of parents were satisfied with treatment, regardless of whether their child received active treatment. (LOE = 1b)

Reference:
Clavenna A, Sequi M, Cartabia M, et al, for the ENBe Study Group. Effectiveness of nebulized beclomethasone in preventing viral wheezing: An RCT. Pediatrics 2014;133(3):e505-12.  [PMID:24534400]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Government

Allocation:
Concealed

Setting:
Outpatient (primary care)

Synopsis:
These Italian investigators enrolled 525 children, aged 1 year to 5 years (mean = 2.1 years), presenting to any of 40 pediatricians with symptoms of acute respiratory tract infection without wheezing. All children had a documented episode of wheezing with a previous respiratory tract infection. The children were randomly assigned, using concealed allocation, to receive beclomethasone 400 mcg or placebo twice daily via nebulizer for 10 days. Children were visited at home if they failed to improve in the first 3 days or if they experienced wheezing, but otherwise were evaluated after 10 days of treatment. Analysis was by intention to treat and was performed on 99.2% of children. Wheezing was diagnosed in 9% of children and was not different between the 2 groups. The study had the power to find a 30% reduction in wheezing between groups if one had existed. At the end of treatment 46% of children still had (nonwheeze) symptoms, with no difference between groups. Approximately two thirds (63%) of parents in both treatment groups were satisfied with treatment. Since there wasn’t a no-treatment group, we cannot tell the degree to which the placebo effect affected parental satisfaction.

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