A systematic review 1 including 30 RCTs was abstracted in DARE. In the formoterol (4 RCTs with 59 children) and salmeterol (5 RCTs with 80 children) studies, some of the children received inhaled steroid. On average, the active drugs produced a statistically significant reduction in the fall in FEV1 on exercise challenge 8 to 12 hours after the drug was given, compared with placebo.
Regular treatment: Monotherapy in steroid-naive children. Salmeterol versus salbutamol (1 RCT with 30 children over 12 weeks): no significant difference in FEV1.
Salmeterol versus inhaled placebo (2 RCTs with 448 children): compared with placebo, salmeterol was associated with a significant increase in FEV1 in one RCT and in morning PEF in both RCTs.
Salmeterol versus beclomethasone dipropionate (2 RCTs with 308 children): the results were inconsistent with both RCTs reporting no significant difference in morning PEF, and one RCT reporting a decrease in FEV1 in the salmeterol group.
Comment: The quality of evidence is downgraded by inconsistency (heterogeneity in interventions and outcomes), review quality and possible publication bias due to limited literature search.
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