title: [The Safety and efficacy of airway-hyperresponsiveness test for asthma using by SK-1211 (Methacholine Chloride)].
abstract: BACKGROUND
  In abroad, Methacholine Chloride (Provocholine®) is used to meet the indications of the diagnosis of bronchial airway hyperreactivity in subjects who do not have clinically apparent asthma. We examined efficacy, safety and pharmacokinetics of Methacholine Chloride (name of study drug: SK-1211) in order to get approved for the airway hyperresponsiveness test in Japan.
  
  
  METHODS
  Fifteen adult healthy volunteers, fifteen adult patients with asthma and ten pediatric patients with asthma were enrolled in this study. The airway hyperresponsiveness test with SK-1211 was conducted in accordance with Japanese Society of Allergology Standard Method.
  
  
  RESULTS
  When the threshold value of PC20 was 8 mg/mL, the sensitivity of adult patients with asthma was 66.7% (10/15 subjects) and the specificity of adult healthy volunteers was 86.7% (13/15 subjects). The sensitivity of pediatric patients with asthma was 70.0% (7/10 subjects). Not all subjects experienced some adverse reactions during inhalation of SK-1211, all of which were mild in severity and resolved soon with inhalation of a bronchodilator. There were no serious adverse reactions reported.
  
  
  CONCLUSIONS
  The airway hyperresponsiveness test with SK-1211 was no specific concern with safety and useful in the diagnosis of bronchial airway hyperresponsiveness.
authors.affiliation: Department of Medicine, Division of Allergology and Respiratory Medicine, Showa University School of Medicine.
authors.forename: Hironori
authors.initials: H
authors.lastname: Sagara
authors.forename: Akihiko
authors.initials: A
authors.lastname: Tanaka
authors.forename: Shin
authors.initials: S
authors.lastname: Ohta
authors.forename: Emi
authors.initials: E
authors.lastname: Jinno
authors.forename: Naoki
authors.initials: N
authors.lastname: Uchida
authors.forename: Takehiko
authors.initials: T
authors.lastname: Sambe
authors.forename: Noriko
authors.initials: N
authors.lastname: Hida
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Suehiro
authors.forename: Satoru
authors.initials: S
authors.lastname: Doi
authors.forename: Makoto
authors.initials: M
authors.lastname: Kameda
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Yoshida
authors.forename: Junji
authors.initials: J
authors.lastname: Fukuoka
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kinoshita
mesh_terms: D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001985:Bronchial Provocation Tests; D001993:Bronchodilator Agents; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D016210:Methacholine Chloride / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D016210:Methacholine Chloride