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Hashiguchi K, Okubo K, Wakabayashi K, et al. The assessment of the optimal duration of early intervention with montelukast in the treatment of Japanese cedar pollinosis symptoms induced in an artificial exposure chamber. J Drug Assess. 2012;1(1):40-7doi: 10.3109/21556660.2012.728547.
Hashiguchi, K., Okubo, K., Wakabayashi, K., Tanaka, N., Watada, Y., Suematsu, K., & Gotoh, M. (2012). The assessment of the optimal duration of early intervention with montelukast in the treatment of Japanese cedar pollinosis symptoms induced in an artificial exposure chamber. Journal of drug assessment, 1(1), 40-7. https://doi.org/10.3109/21556660.2012.728547
Hashiguchi, Kazuhiro, et al. "The assessment of the optimal duration of early intervention with montelukast in the treatment of Japanese cedar pollinosis symptoms induced in an artificial exposure chamber." Journal of drug assessment vol. 1,1 (2012): 40-7. doi: https://doi.org/10.3109/21556660.2012.728547
Hashiguchi K, Okubo K, Wakabayashi K, Tanaka N, Watada Y, Suematsu K, Gotoh M. The assessment of the optimal duration of early intervention with montelukast in the treatment of Japanese cedar pollinosis symptoms induced in an artificial exposure chamber. J Drug Assess. 2012 Oct 09;1(1):40-7. doi: 10.3109/21556660.2012.728547. eCollection 2012. PMID: 27536427; PMCID: PMC4980728.
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J Drug Assess. 2012 Oct 09;1(1):40-7. doi: 10.3109/21556660.2012.728547. eCollection 2012.

The assessment of the optimal duration of early intervention with montelukast in the treatment of Japanese cedar pollinosis symptoms induced in an artificial exposure chamber.

Journal of drug assessment

Kazuhiro Hashiguchi, Kimihiro Okubo, Ken-Ichiro Wakabayashi, Nobuaki Tanaka, Yukiko Watada, Kiyochika Suematsu, Minoru Gotoh

Affiliations

  1. Department of Otolaryngology, Futaba Clinic, TokyoJapan.
  2. Department of Otolaryngology, Nippon Medical School, TokyoJapan.
  3. Department of Otorhinolaryngology, Kitasato Institute Hospital, TokyoJapan.
  4. Tanaka ENT Clinic, Tokyo, Japan; Department of Otorhinolaryngology, Tokyo Women's Medical University Medical Center East, TokyoJapan.
  5. Department of Otorhinolaryngology, Keio University School of Medicine, TokyoJapan.
  6. Pharmaceutical Department, Medical Corporation Shinanokai, Samoncho Clinic, TokyoJapan.

PMID: 27536427 PMCID: PMC4980728 DOI: 10.3109/21556660.2012.728547

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.

Keywords: Early intervention; Environmental exposure chamber; Japanese cedar pollinosis; Montelukast Clinical Trial Registration: UMIN Clinical Trials Registry number

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