[Preventive monotherapy with montelukast versus DNCG in children with mild asthma. Results of and exploratory pilot study]

Abstract

Background: Montelukast is used as an add-on medication with inhaled steroids in the therapy of childhood asthma. The aim was to determine the clinical effect of montelukast as a prophylactic therapy in mild asthma in comparison with inhaled sodium cromoglycate.

Method: 20 children aged 6-14 years were treated in a 20-week open-labelled randomized cross-over design, starting after a 2-week run-in period with either montelukast or cromolyn for 16 weeks with a 2-week wash-out period between treatments.

Results: Children treated with cromoglycate showed a significant increase of FEV1 (100.6 vs. 96.5%, p < 0.01) and MEF25 (70.6 vs. 59.1%, p < 0.05) in base line lung function and after cold air challenge (FEV1 97.2 vs. 91.2%, p < 0.05; MEF25 62.9 vs. 54.4%, p < 0.01). Treatment with montelukast effected a significant increase (p < 0.05) in MEF25 from 59.1 to 67.8% in base line lung function alone. Both medications resulted in significant decreases (p < 0.05) in daytime asthma symptoms and evening peak flow variability. Comparing the two treatment substances no statistically significant differences could be registered in any endpoints including beta-agonist use.

Conclusions: Both cromolyn and montelukast showed effective control of mild asthma in children; however, montelukast is more convenient in its application. Further studies are needed to determine the role of leukotriene receptor antagonists in childhood asthma.