Comparison of oral montelukast and inhaled cromolyn with respect to preference, satisfaction, and adherence: A multicenter, randomized, open-label, crossover study in children with mild to moderate persistent asthma

Objective: The aim of this study was to compare parent and child preference, satisfaction, and adherence of oral montelukast, a leukotriene receptor antagonist, with those of inhaled cromolyn. Background: Parents are actively involved in the care of their young children with asthma. Parent and child preference and satisfaction are critical in maintaining adherence to asthma therapy and achieving optimal therapeutic outcomes. Methods: Children aged 6 to 11 years with mild to moderate persistent asthma entered a multicenter, randomized, open-label, crossover trial. Children received montelukast (one 5-mg chewable tablet at bedtime) or cromolyn (2 mg 4 times daily via metered-dose inhaler), each for 4 weeks. A 2-week washout period separated the treatment periods. Parent and child preference for montelukast versus cromolyn and satisfaction with each treatment were assessed with 1-question preference and multiquestion satisfaction questionnaires. Adherence with study medications and beta-agonist use was assessed by means of diary cards. Results: Two hundred sixty-six children entered the trial. Of 254 parents included in the analysis, 249 parents (98%) expressed a preference; of these, significantly more preferred oral montelukast over inhaled cromolyn (219 [88%] vs 30 [12%], P < 0.001). Similarly, significantly more children expressed a preference for montelukast over cromolyn (201 [80%] vs 50 [20%], P < 0.001). Parents and children both expressed significantly greater satisfaction with montelukast than with cromolyn across all questions in the questionnaires (P < 0.001). Two hundred fourteen children (84%) were highly adherent (>95% of days) to montelukast therapy, whereas 122 children (48%) were adherent to cromolyn therapy (P < 0.001). Daily beta-agonist use was significantly lower during montelukast therapy than during cromolyn therapy (P = 0.001). Both therapies were generally well tolerated. Conclusions: Parent and child preference, satisfaction, and adherence were all significantly better with oral montelukast compared with inhaled cromolyn. Treatment with oral montelukast may improve the outcomes of asthma therapy in children.