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 beta-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 beta-agonists and leukotriene antagonists on FEV1 and exhaled nitric oxide levels (FENO) in children. Methods: Forty-eight steroid-naive 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 mu g twice daily; second month: budesonide 400 mu g twice daily; (2) first month: budesonide 200 mu g twice daily+formoterol 9 mu g twice daily; second month: budesonide 200 mu g twice daily+montelukast 5 mg once daily; (3) first month: budesonide 200 mu g twice daity+montelukast 5 mg once daily; second month budesonide 200 mu g+formoterol 9 mu g twice daily; (4) first and second month: budesonide 400 mu g 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 combination was 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 beta-agonists or doubling the dose of budesonide for controlling FENO in asthmatic children. (c) 2007 Elsevier Ltd. All rights reserved.