Methods: open clinical trial study was carried out to evaluate the therapeutic effect and safety of Montelukast 10 mg in patients with rhinitis and persistent moderate and severe asthma, not controlled, according to the GEMA 2009 guidelines. This drug was administered once a day before bed for six months. 60 asthmatic subjects were recruited and 56 completed the study that was conducted from October 2008 to June 2009. The evaluation included clinical symptoms and used medication at the beginning, 3 months and 6 months with treatment. The safety evaluation included control of renal and liver function, the appearing of adverse events. There were also carried out tests of breathing function at first month and 6 months of treatment
Results: There were differences respect to clinical improvement and decrease of use of concomitant medication (89% cases). FEV1 (forced expiratory volume in 1 second) values were significantly (p < 0.01) improved after treatment with Montelukast during 6 months when compared with the measurements registered before treatment (FEV1 Baseline). Only five patients reported adverse events (9%), in 2 of the cases was necessary to stop treatment. The headache was the most reported event (3 cases).
Conclusions: The administration of Montelukast 10 mg once daily was well tolerated and safety. The treatment was considered effective because 89% cases were classified as better in the evaluation according to reduction consumption of medications daily and symptoms score in patients with moderate and severe asthma and allergic rhinitis.