title: Pranlukast dry syrup inhibits symptoms of Japanese cedar pollinosis in children using OHIO Chamber.
abstract: Pranlukast (PLK) is a leukotriene receptor antagonist (LTRA) that has been approved for treatment of asthma in patients of all ages and allergic rhinitis (AR) in adults but not for AR in children in Japan. This randomized, double-blind, placebo-controlled, crossover study used an artificial  exposure chamber (OHIO Chamber) to investigate the efficacy and safety of PLK in children from 10 to 15 years old with seasonal AR (SAR) due to Japanese cedar (JC) pollen. Eighty-four subjects were enrolled and randomized to the treatment arm and 74 were included in the per protocol set. Subjects  received either PLK dry syrup (DS) or placebo for 1 week. They were challenged with JC pollen in the OHIO Chamber for 3 hours. Total nasal symptom scores (TNSSs) were recorded every 30 minutes during the exposure. PLK DS treatment suppressed the TNSS changes from baseline significantly when  compared with placebo. The difference in the least square means in TNSS between the PLK DS-treated group and placebo group was -0.37 (95% CI, -0.54, -0.20) with a value of p < 0.0001, showing that PLK DS significantly suppressed the nasal symptoms. Regarding specific  nasal symptoms, PLK DS significantly suppressed sneezing, nasal discharge, and nasal obstruction. The effect of PLK DS on nasal obstruction was most prominent, with significant improvement relative to placebo beginning 60 minutes after the start of exposure. No serious adverse events were  reported during the study. In this study, PLK DS is effective and safe for treatment in children with SAR.
authors.affiliation: Department of Otorhinolaryngology, Kitasato Institute Hospital, Tokyo, Japan. wakabayashi-kenichiro@nifty.com
authors.forename: Ken-ichiro
authors.initials: K
authors.lastname: Wakabayashi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Hashiguchi
authors.forename: Sho
authors.initials: S
authors.lastname: Kanzaki
authors.forename: Masato
authors.initials: M
authors.lastname: Fujioka
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Tanaka
authors.forename: Kayoko
authors.initials: K
authors.lastname: Kawashima
authors.forename: Kiyochika
authors.initials: K
authors.lastname: Suematsu
authors.forename: Hajime
authors.initials: H
authors.lastname: Yamamotoya
authors.forename: Manabu
authors.initials: M
authors.lastname: Iwasaki
authors.forename: Minoru
authors.initials: M
authors.lastname: Gotoh
authors.forename: Seiji
authors.initials: S
authors.lastname: Horibe
authors.forename: Kensei
authors.initials: K
authors.lastname: Naito
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Okubo
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000485:Allergens / Q000009:adverse effects / Q000276:immunology; D001273:Atmosphere Exposure Chambers / Q000706:statistics & numerical data*; D002648:Child; D002867:Chromones / Q000008:administration & dosage* / Q000009:adverse effects; D032485:Cryptomeria / Q000276:immunology*; D005260:Female; D006801:Humans; D007114:Immunization; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D015508:Nasal Obstruction / Q000188:drug therapy* / Q000209:etiology; D011058:Pollen / Q000009:adverse effects; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000188:drug therapy*
chemical_list: D000485:Allergens; D002867:Chromones; D020024:Leukotriene Antagonists; C047681:pranlukast