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Montelukast plus levocetirizine improves allergic rhinitis outcomes in asthma patients

Jairia Dela Cruz
07 Aug 2018

The fixed-dose combination of montelukast plus levocetirizine produces greater improvements in allergic rhinitis symptoms as compared with montelukast alone in patients with concurrent mild-to-moderate asthma, according to the results of a phase III trial. Moreover, the combination is well tolerated with an acceptable safety profile.

Based on the present data, the investigators believe that the fixed-dose combination of the two widely used therapeutic drugs will provide significantly improved rhinitis outcomes in patients with allergic rhinitis and asthma.

The trial randomized 210 adult patients (mean age 43.32 years; 66.67 percent female; 84.29 percent had mild asthma) to treatment with either montelukast plus levocetirizine (10 and 5 mg/day, respectively; n=116) or montelukast monotherapy (10 mg/day; n=112) for 4 weeks after a 1-week placebo run-in period.

Reductions in mean daytime nasal symptom score, the primary efficacy endpoint, was significantly greater in the combination than in the montelukast-alone group (–0.98 vs –0.81; p=0.045). Patients on montelukast/levocetirizine also exhibited a marked decrease in sneezing (p=0.005), as well as marginal improvements in rhinorrhoea, itching and nasal obstruction (p=0.060–0.387). [Clin Ther 2018;doi:10.1016/j.clinthera.2018.04.021]

However, no significant between-group differences were observed for asthma outcomes, including forced expiratory volume in 1 second (FEV1; p=0.6848), forced vital capacity (FVC; p=0.6632), FEV1/FVC (p=0.9459) and asthma control test score (p=0.3604).

Total and mean daily frequencies of rescue medication use during the treatment period were significantly higher in the combination vs the montelukast group (mean total use, 15.62 vs 8.51; p=0.035; mean daily usage, 0.53 vs 0.29; p=0.039).

Montelukast/levocetirizine was well tolerated, with treatment-emergent adverse events (TEAEs) occurring in 16.67 percent of patients vs 16.36 percent in the monotherapy group. Commonly reported AEs in the combination group included upper respiratory tract infection, nasopharyngitis, gastrointestinal disorder and tonsillitis.

“Allergic rhinitis and asthma have long been regarded and treated as separate disorders,” the investigators noted.

However, evidence shows that the severity of rhinitis is linked to the severity of coexisting asthma, and that rhinitis not only worsens asthma prognosis but also lowers quality of life by limiting daily activities and reducing efficiency at work. This association may be explained by the anatomic, physiological and immunologic mechanisms of the upper and lower airways. [BMC Plum Med 2006;6:S3; Clin Exp Allergy 2005;35:282-287]

“All of this information indicates that rhinitis and asthma are manifestations of either the same or similar inflammatory processes that develop in the common respiratory tract tissue. It is therefore important that rhinitis and asthma not be evaluated as separate disorders, and both [conditions] need to be treated when they coexist,” they added.

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