Abstract
Our aim was to directly compare anti-inflammatory activity, as measured by fraction of exhaled nitric oxide (FeNO), relative efficacy, and safety of a low-dose inhaled corticosteroid and a leukotriene modifier in children with mild to moderate persistent asthma. Twentyfour children, 5–12 years old, on inhaled corticosteroids were switched to salmeterol for a 2-week run-in period, then randomized to treatment. Subjects received 4 weeks of therapy with placebo, montelukast, or fluticasone propionate in a randomized, double-blind, doubledummy, three-way crossover fashion. FeNO and spirometry were measured at baseline and every 2 weeks. Fluticasone propionate resulted in significantly lower FeNO after 2 and 4 weeks (10.78 and 11.0 ppb) compared to montelukast (14.69 and 15.6 ppb) and placebo (13.1 and 13.9 ppb). FeNO after 4 weeks of montelukast (15.6 ppb) was significantly increased compared to baseline (11.7 ppb) and salmeterol (13.0 ppb) but was not different from placebo (13.9 ppb). Post-bronchodilator forced expiratory volume in 1 sec, percent predicted (FEV1%) was significantly higher following fluticasone propionate compared to placebo after 2 and 4 weeks, and was greater than montelukast after 2 weeks. Evening (PM) asthma score was significantly lower after 2 weeks of fluticasone propionate compared to salmeterol, montelukast and placebo. In children with mild to moderate persistent asthma, fluticasone propionate provides a significant reduction in FeNO compared to montelukast. Montelukast failed to lower FeNO compared to placebo. (Pediatr Asthma Allergy Immunol 2005; 18[3]:123–130.)
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