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Abstract
Background. Loratadine added to montelukast has been suggested to improve endpoints of asthma. Objective. This study investigated the additive effects of concomitant montelukast and loratadine when compared with montelukast, loratadine, and inhaled beclomethasone monotherapies in asthma. Methods. Patients (N = 406) were 15 to 65 years of age with a forced expiratory volume in 1 second (FEV1)-predicted of 50% to 85%, FEV1 reversibility ≥ 15%, and a minimal level of daytime symptoms and β -agonist use. This three-part 2X2 crossover-study consisted of two double-blind 6-week treatment periods where patients were administered once daily oral montelukast 10 mg, loratadine 10 mg, montelukast 10 mg + loratadine 10 mg, or twice daily inhaled beclomethasone 200 μ g. A subsequent 48-week extension study compared montelukast+loratadine with beclomethasone. The primary endpoint was the percentage change from baseline in FEV1. Results. Over 6 weeks of double-blind treatment, significant improvements (p < 0.05) in the primary endpoint of FEV1 were seen for montelukast+loratadine versus loratadine (least-square mean percentage-point difference of 5.8%), beclomethasone versus montelukast+loratadine (2.35%), montelukast versus loratadine (5.94%), and beclomethasone versus montelukast (4.65%); a numerical improvement (p = 0.054) was seen for montelukast+loratadine versus montelukast (1.60%). Significant improvements for montelukast+loratadine versus montelukast were seen in some secondary endpoints (evening peak expiratory flow, nocturnal asthma symptom score, nocturnal awakenings, and asthma-specific quality of life) but not others. Significant improvements in most endpoints except daytime asthma symptoms score were seen for montelukast+loratadine versus loratadine. In the extension study, both montelukast+loratadine and beclomethasone improved several endpoints. All treatments were generally comparable in the percentage of patients with clinical and laboratory adverse experiences. Conclusion. In this study, the addition of loratadine to montelukast produced a small numerical, but not statistically significant, improvement in FEV1 and, in general, no consistent improvement in other asthma endpoints. No improvement of montelukast+loratadine versus beclomethasone was seen in any endpoint.