Formoterol, montelukast, and budesonide in asthmatic children: Effect on lung function and exhaled nitric oxide

SummaryBackgroundIt has been proposed that asthma control may be achieved in part by minimizing airway inflammation. The simultaneous effects of inhaled steroids associated with long-acting β-agonists and leukotriene antagonists on pulmonary function and airway inflammation are still largely unexplored in children with moderate persistent asthma.ObjectivesThe aim of this study was to investigate the effects of add-on therapy with long-acting β-agonists and leukotriene antagonists on FEV1 and exhaled nitric oxide levels (FENO) in children.MethodsForty-eight steroid-naïve atopic asthmatic children, 7–11 years of age, were randomly treated in four groups for two consecutive one-month periods, as follows: (1) first month: budesonide 200 μg twice daily; second month: budesonide 400 μg twice daily; (2) first month: budesonide 200 μg twice daily+formoterol 9 μg twice daily; second month: budesonide 200 μg twice daily+montelukast 5 mg once daily; (3) first month: budesonide 200 μg twice daily+montelukast 5 mg once daily; second month budesonide 200 μg+formoterol 9 μg twice daily; (4) first and second month: budesonide 400 μg twice daily.ResultsAll treatments resulted in a significant increase in lung function and a decrease in FENO compared with values at baseline. Budesonide+montelukast in combination was the most effective treatment for reducing FENO levels.ConclusionThis study demonstrates that add-on therapy with montelukast plus low-dose budesonide is more effective than the addition of long-acting β-agonists or doubling the dose of budesonide for controlling FENO in asthmatic children.