Randomized placebo‐controlled trial comparing montelukast and cetirizine for treating perennial allergic rhinitis in children aged 2–6 yr

Abstract

Leukotriene receptor antagonists (LTRAs) were recently added to the method of treating allergic rhinitis (AR). However, in children under 6 yr old, there has been no study about its efficacy in treating AR. We aim to compare the clinical efficacy of montelukast, cetirizine and placebo in the treatment of children from 2 to 6 yr old with perennial allergic rhinitis (PAR), to see if there are any significant differences. Sixty children were selected and treated with montelukast, or cetirizine, or placebo once daily. The efficacy of the three agents was compared with the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) and Total Symptom Score (TSS) by diary. In addition, we also examined serum IgE, serum eosinophil cationic protein (ECP), blood eosinophil counts, nasal airway resistance (NAR) and eosinophil percentage in nasal smears. The results revealed that both montelukast and cetirizine were significantly efficacious compared with placebo in NAR, eosinophil percentage in nasal smears, PRQLQ, TSS and all symptom items except nasal itching, throat itching and tearing. For nasal itching, only cetirizine was significantly efficacious. On the other hand, for night sleep quality, montelukast was significantly superior to cetirizine.

Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology

“…Symptoms of congestion are only effectively controlled by nasal corticosteroids (120) (B). In children, there are insufficient comparative data to determine whether antihistamines or montelukast is more effective, although some studies indicate that antihistamines are more effective for itching (121,122). Antihistamines and montelukast may provide some additional benefit when used as add-on therapy with nasal corticosteroids (73, 74, 118, 120)(B).…”

Montelukast: Pharmacology, Safety, Tolerability and Efficacy

“…42 A randomized placebo-controlled trial has also shown efficacy of montelukast in comparison to placebo in total nasal symptom scores and a quality of life questionnaire in children 2-6 years of age. 43 Studies have also shown the effectiveness of montelukast in comparison to placebo in both seasonal and perennial AR patients in both adults and children as part of trials that evaluated montelukast in combination with other medications. 44,45 This improvement included the control of daily symptoms of nasal congestion, itching, sneezing and rhinorhea as well as other endpoints such as eye symptoms, global evaluations, nighttime symptom scores and quality of life surveys.…”

“…56 In children 2-6 years old, montelukast was equivalent to cetirizine in the management of nasal symptoms of perennial AR except for nasal itching which was better controlled with cetirizine. 43 Montelukast in combination with cetirizine showed better control of the clinical nasal symptoms and reduced eosinophil counts better than either montelukast or cetirizine alone in seasonal AR patients. 57 When given 6 weeks before the start of the pollen season this combination delayed the onset of allergic seasonal symptoms in comparison to monotherapy.…”

Effects of Leukotriene Receptor Antagonists on Peripheral Eosinophil Counts and Serum IgE Levels in Children with Food Allergy

“…[24][25][26] Clinical allergic symptoms as well as eosinophil count, serum IgE, and IL-4 levels have been shown to drop significantly after LTRA treatment in children with allergic rhinitis and Kimura's disease. [27][28][29] The effectiveness of LTRAs was also reported in allergic eosinophilic esophagitis, a rarely diagnosed condition involving eosinophil infiltration of the esophageal mucosa among infants. [30] Serum IgE levels were significantly increased in the control group as a natural course of illness despite dietary treatment, but were significantly decreased in the LTRA group.…”