Objective: To compare the efficacy of nasal budesonide plus oral zafirlukast against nasal budesonide plus oral loratadine/pseudoephedrine combination in the control of symptoms of rhinitis and asthma.
Patients and methods: A controlled, clinical, randomized, double blind and crossover study was made in 36 patients with allergic rhinitis and asthma following one of the next treatment regimes: group a) nasal budesonide plus oral zafirlukast twice a day or group b) nasal budesonide plus oral loratadine/pseudoephedrine twice a day, both of them during six weeks, and two weeks of washing and crossover of the treatments during six more weeks. Changes in the rhinitis and asthma symptoms, blood eosinophils, pulmonary function testing, and nasal cytology were evaluated before and after the treatment.
Results: 19 patients were assigned to group a, whereas 17 patients to group b. The age ranged between 16 to 45 years, and it predominated the female group, 70 and 89%, respectively (statistically no significant). During the first six weeks of the treatment, V0 to V3, both groups of patients got better nasal symptoms but group a was superior to group b. However, in bronchial symptoms, cough, wheezing and breathlessness, group a showed efficacy in comparison with group b, where no significant improvement was shown. Once the crossover was made, from V5 to V7, there was no difference between both groups. The other evaluated indicators, such as eosinophilia, VEF1 and nasal eosinophils, had a significant improvement before and at the end of the study.
Conclusions: The association of a nasal steroid with a leukotriene modifier (zafirlukast) was more effective for controlling nasal symptoms and especially bronchial symptoms than the association of a nasal steroid with antihistamines (loratadine) with pseudoephedrine. Other inflammation indicators, such as eosinophilia and nasal eosinophilia, were diminished; the VEF1 increased significantly in both treatment groups. All the above may be due to the nasal steroid use associated to a leukotriene modifier.