Background: Asthma and seasonal allergic rhinitis (SAR) are recognized as manifestations of a single airway disease. Desloratadine has demonstrated efficacy in treating SAR symptoms, including nasal obstruction. Methods: Safety and efficacy of desloratadine and montelukast each were assessed in a double-blind, placebo-controlled trial of patients with SAR and symptoms of asthma, who were assigned randomly to once-daily treatment with desloratadine 5 mg, montelukast 10 mg, or placebo for 4 weeks. Change from baseline of AM/PM reflective total asthma symptom severity scores (TASS), FEV1, individual asthma symptom scores, and β2-agonist usage were assessed. Results: Desloratadine and montelukast each were associated with statistically significant reductions from baseline in the mean TASS averaged over the 4-week period (p ≤0.022 vs. placebo). Individual asthma symptom scores also improved significantly for both therapies (p ≤ 0.05). Patients treated with desloratadine or montelukast demonstrated improvement from baseline in FEV1 versus placebo; significant improvement was seen in a subset of patients with baseline FEV1 <80% of predicted normal (both p < 0.05). Both active therapies significantly reduced β2-agonist use (both p < 0.01). Improvements for both therapies were comparable for all efficacy parameters; they were tolerated well with adverse event profiles similar to placebo. Conclusions: Asthma symptoms and β2-agonist were improved significantly in patients with concomitant SAR and asthma treated with desloratadine 5 mg as well as montelukast 10 mg once daily. Both therapies significantly improved FEV1 in a subset of patients with FEV1 <80% of predicted normal at entry. Improvements in asthma symptoms were comparable for both active treatment groups.

Keywords:
Antihistamine, Asthma, Desloratadine, Efficacy, Leukotriene, Montelukast, Safety, Seasonal allergic rhinitis
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2003
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