title: Safety and efficacy of short-term oral immunotherapy with Cry j 1-galactomannan conjugate for Japanese cedar pollinosis: a randomized controlled trial.
abstract: Current allergen-specific immunotherapy (AIT) for pollinosis requires long-term treatment with potentially severe side effects. Therefore, development of an AIT that is safe and more convenient with a shorter regimen is needed. This prospective, double-blind, placebo-controlled trial randomized 55 participants with Japanese cedar pollinosis (JCP) to active or placebo groups to test the safety and efficacy of short-term oral immunotherapy (OIT) with Cry j 1-galactomannan conjugate for JCP. Mean symptom-medication score as the primary outcome in the active group improved 27.8% relative to the placebo group during the entire pollen season. As the secondary outcomes, mean medication score in active group improved significantly, by 56.2%, compared with placebo during the entire pollen season. Mean total symptom score was similar between active and placebo groups during the entire pollen season. There were no severe treatment-emergent adverse events in the active and placebo groups. Therefore short-term OIT with Cry j 1-galactomannan conjugate is safe, and effective for reducing the amount of medication use for JCP.
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.|Department of Otorhinolaryngology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Murakami
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Motohiro
authors.initials: M
authors.lastname: Sawatsubashi
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Omori
authors.affiliation: Bio &Healthcare Business Group, Bio &Healthcare Business Division, Wako Filter Technology Co., Ltd., Ibaraki, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Saito
authors.affiliation: Department of Biological Chemistry, Yamaguchi University, Yamaguchi, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Kato
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Shizuo
authors.initials: S
authors.lastname: Komune
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Nakagawa
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D032485:Cryptomeria / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000009:adverse effects*; D005260:Female; D005690:Galactose / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008351:Mannans / Q000276:immunology*; D011058:Pollen / Q000276:immunology*; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology* / Q000473:pathology / Q000628:therapy*; D012621:Seasons; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D008351:Mannans; C012990:galactomannan; D005690:Galactose