Abstract
Objective:The study objective was to investigate the prophylactic efficacy of montelukast (MLK) 10 mg in suppressing seasonal allergic rhinitis (SAR) symptoms induced by Japanese cedar (JC) pollen and to determine how many days before exposure to JC in the artificial exposure chamber (OHIO chamber) would be optimal to start administration.Methods:This was a single-institution, double-blind, randomized placebo-controlled four-group parallel inter-group comparison study. Adult volunteers with JC pollinosis were divided into four groups: an MLK 7-day administration group (n = 27), an MLK 3-day administration group (n = 27), an MLK 1-day administration group (n = 26), and a placebo group (n = 26). The mean change in total nasal symptom scores (nasal obstruction, nasal discharge and sneezing) (TNSS) and each of the nasal symptom scores during exposure of JC pollen in the OHIO chamber were investigated.Results:The mean change in TNSS was significantly lower in the MLK treatment group, regardless of the number of days of administration, than in the placebo group (p = 0.0192). The results for the individual nasal symptoms showed that nasal obstruction was significantly suppressed in the 1-day administration group as compared with placebo (p = 0.0076), but no differences were found in sneezing score between any of the groups. For nasal discharge, we found a trend towards the effect clearing up after 3 days of administration. No serious adverse events were observed during the study.Conclusion:Although this study was acute and this artificial exposure model was conducted out of the pollen season, nasal symptoms that developed in the pollen exposure chamber, especially nasal obstruction, were significantly suppressed by starting oral administration of MLK 10 mg at least 1 day before exposure. These results suggest that prophylactic administration of MLK is effective and safe in the treatment of SAR.
Highlights
The prevalence of seasonal allergic rhinitis (SAR) has been increasing over the last decade and affects up to about 30% of the Japanese population[1]
This study was acute and this artificial exposure model was conducted out of the pollen season, Otolaryngology, Futaba Clinic, 20 Samon-cho, nasal symptoms that developed in the pollen exposure chamber, especially nasal obstruction, were
Tel.: þ81 3-3351-4133; Fax: þ81 3-3351-4133; These results suggest that prophylactic administration of MLK is effective and safe in the treatment of SAR
Summary
The prevalence of seasonal allergic rhinitis (SAR) has been increasing over the last decade and affects up to about 30% of the Japanese population[1]. Since the land-shape of Japan is long in the north–south direction and possesses four distinct seasons with different climates within the different regions, pollen from more than 4500 kinds of weeds and trees disperse all over the country. 2012 Informa UK Ltd. there are patients with pollinosis to each of these various pollens, Japanese cedar (JC) pollen is the cause of seasonal allergic rhinitis with the largest number of patients. According to a recent epidemiological study, the prevalence of JC pollinosis is 26.5% and an approximately 10% increase has been observed over the past 10 years[1]. An increase in the amount of JC pollen in the past decade has been cited as one reason for this
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