Efficacy and Safety of Montelukast+Levocetirizine Combination Therapy Compared to Montelukast Monotherapy for Allergic Rhinitis in Children
Abstract
PURPOSE: The combination therapy of leukotriene receptor antagonists and antihistamines may alleviate allergic rhinitis (AR) symptoms better than monotherapy. This study aimed to investigate the safety and efficacy of Monterizine®, a fixed-dose combination of montelukast and levocetirizine, compared to montelukast monotherapy in pediatric patients with AR.
METHODS: One hundred seventy-six children aged 6 to 14 years with perennial AR symptoms were recruited. One hundred forty-seven subjects were randomized into 1 of 2 groups: the mont+levo group (fixed-dose combination of montelukast [5 mg] + levocetirizine [5 mg]) or the mont group (montelukast single agent [5 mg]). Study subjects took the treatment every evening for 4 weeks and recorded their daytime nasal symptom score (DNSS) and nighttime nasal symptom score (NNSS) in a diary every day. Adverse events (AEs) were also recorded, and patients were surveyed as to their overall satisfaction with the therapeutic product they received.
RESULTS: When DNSS and NNSS were assessed individually, daytime nasal congestion symptom scores decreased more in the mont+levo group during the 4-week treatment period than in the mont group (P = 0.0341). The daytime rhinorrhea symptom scores also decreased more in the mont+levo group (P = 0.0469). The nighttime nasal congestion score (severity when awake) decreased more in the mont+levo group than in the mont group (P = 0.0381). Study subjects in the mont+levo group experienced a greater…
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