A Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Montelukast/Levocetirizine Combination Therapy Compared to Montelukast Monotherapy for Allergic rhinitis With or Without Asthma in Children

초록

RATIONALE: Leukotriene receptor antagonists (LTRAs) and anithistamine combination therapy may alleviate AR symptoms better than mono therapy. This study proposed to investigate the safety and efficacy of Monterizine (fixed-dose combination of Montelukast + Levocetirizine) compared to monotherapy with Montelukast in pediatric patients with allergic rhinitis (AR). METHODS: 176 children aged 6 to 14 years old with perennial AR symptoms were recruited. 147 subjects were randomized into 1 of 2 groups: the "Mont/Levo Group" [fixed-dose combination of Montelukast (5mg) + Levocetirizine (5mg)] or the control group "Mont Group" [Montelukast single agent (5mg)]. Study subjects took the treatment every evening for 4 weeks and wrote down their daytime nasal symptom score (DNSS) and nighttime nasal symptom score (NNSS) in the diary every day. Adverse events (AEs) were also recorded. 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 (P50.0341). The daytime rhinorrhea symptom scores also decreased more in the Mont/ Levo Group (P50.0469). The NNSS "severity of nasal congestion when awake" decreased more in the Mont/Levo Group than in the Mont Group (P50.0381). Study subjects in the Mont/Levo Group experienced a greater improvement in quality of life (QoL) than subjects in the Mont Group (P<0.0001). CONCLUSIONS: The combination therapy of Montelukast and Levocetirizine was more effective at reducing both daytime nasal symptoms and nighttime nasal symptoms. With fewer AEs and higher overall satisfaction, combination therapy is recommended for pediatric patients with perennial AR.