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Randomized Controlled Trial
. 2007 Aug;101(8):1809-13.
doi: 10.1016/j.rmed.2007.02.010. Epub 2007 Apr 5.

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

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Free article
Randomized Controlled Trial

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

Michele Miraglia del Giudice et al. Respir Med. 2007 Aug.
Free article

Abstract

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-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 microg twice daily; second month: budesonide 400 microg twice daily; (2) first month: budesonide 200 microg twice daily+formoterol 9 microg twice daily; second month: budesonide 200 microg twice daily+montelukast 5mg once daily; (3) first month: budesonide 200 microg twice daily+montelukast 5mg once daily; second month budesonide 200 microg+formoterol 9 microg twice daily; (4) first and second month: budesonide 400 microg 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.

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