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 improvement in quality of life than subjects in the mont group (P < 0.0001).

Conclusions: The combination therapy of montelukast and levocetirizine was more effective in reducing both daytime nasal symptoms (nasal congestion and rhinorrhea) and nighttime nasal symptoms (severity of nasal congestion when awake). With fewer AEs and higher overall satisfaction, combination therapy is recommended for pediatric patients with perennial AR.

Keywords: Rhinitis, allergic; cetirizine; child; drug combinations; histamine antagonists; leukotriene antagonists; montelukast.

Fig. 1. Subject selection flow.

FAS, full analysis set; PPS, per protocol set.

Fig. 2. Comparison of nasal symptom scores for nasal congestion between the mont+levo group and the mont group in the FAS. (A) Changes in daytime nasal congestion scores from Visit 2 (Baseline) to Visit 3 (Week 4) differed between the two groups, with a statistically significant between-group difference (P = 0.0341). (B) Changes in the severity of nighttime nasal congestion when awake from Visit 2 (Baseline) to Visit 3 (Week 4) differed between the two groups, with a statistically significant between-group difference (P = 0.0381).

FAS, full analysis set. ^*P < 0.05.

Fig. 3. Comparison of daytime nasal symptom scores for rhinorrhea between the mont+levo group and the mont group in the FAS. Changes in daytime rhinorrhea scores from Visit 2 (Baseline) to Visit 3 (Week 4) differed between the two groups, with a statistically significant between-group difference (P = 0.0469).

FAS, full analysis set. ^*P < 0.05.

Fig. 4. Comparison of the total PRQLQ scores between the mont+levo group and the mont group in the FAS. Changes in the total PRQLQ scores from Visit 2 (Baseline) to Visit 3 (Week 4) differed between the two groups, with a statistically significant between-group difference (P < 0.0001).

PRQLQ, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire. ^*P < 0.05.

Fig. 5. Comparison of the overall treatment of effect at the end of the study using a 7-point Likert scale between the mont+levo group and the mont group in the FAS. Statistically significant differences were observed in both (A) subjects’ assessment (P < 0.0001) and (B) investigators’ assessment (P < 0.0001).

^****P < 0.0001.