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

Background: It 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. Objectives: The 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. Methods: Forty-eight steroid-naïve atopic asthmatic children, 7 to 11 years of age, were randomly treated in four groups fortwo 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. Results: All treatments resulted in a significant increase in lung function and a decrease in FENO compared with values at baseline. Budesonide + montelukast in combinationwas the most effective treatment for reducing FENO levels. Conclusion: This 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.