Montelukast versus formoterol as second-line therapy in asthmatic children exposed to relevant allergens.

In sensitive asthmatic children, the exposure to relevant allergens causes a deterioration of lung function and symptoms associated with an increase of inflammatory indices. The aim of this single-blind randomized add-on study was to compare the effects of montelukast or formoterol added to low-dose budesonide in asthmatic allergic children exposed to relevant allergens. Twenty children (5 female subjects and 15 male subjects, aged 6-12 years) were enrolled. Lung function and airway inflammatory indices (exhaled nitric oxide [eNO] and sputum eosinophils) were evaluated at T0 when children were not exposed to relevant allergens and at T1 after 15 days of natural effective allergen exposure. At T1, pulmonary function tests and sputum eosinophils remained stable in both of the groups, without significant differences in comparison with T0 at baseline. Furthermore, formoterol plus budesonide was effective in preventing the expected increase in eNO from 26.46 +/- 2.62 ppb at T0 to 29.33 +/- 9.28 ppb at T1 (not significant). However, in the group receiving montelukast plus budesonide, there was a significant decrease of eNO from baseline (30.78 +/- 6.87 ppb) to T1 (18.17 +/- 6.60 ppb) (p < .05). In allergic asthmatic children, the use of montelukast or formoterol combined with budesonide could offer a durable protective effect on symptoms, lung function, and inflammatory indices.

RCT Entities:   Population Interventions Outcomes