title: The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients.
abstract: OBJECTIVE
  In Japan, the Asthma Prevention and Management Guidelines recommend nebulized β-agonists, IV (intravenous) drip corticosteroids, as well as IV drip aminophylline for acute asthma treatment. However, current treatment for acute asthma provides inadequate benefit for some patients. We evaluated the efficacy and safety of IV montelukast added to standard therapy in Japanese patients with acute asthma exacerbations.
  
  
  METHODS
  This multicenter, randomized, double-blind, parallel-group study compared IV montelukast 7 mg, 14 mg, and placebo in Japanese patients with acute asthma exacerbations (N = 242). Fifteen- to sixty-five-year-old patients with acute asthma were treated with standard care during a screening period that lasted ≤60 minutes. Patients with FEV(1) (forced expiratory volume in 1 second) ≤70 predicted were randomly allocated to one of three treatment groups. The primary end point was the time-weighted average change in FEV(1) from baseline over 60 minutes [ΔFEV(1) (0-60 minutes)] after study drug administration. Secondary end points included the time-weighted average change in FEV(1) over 20, 40, and 120 minutes [ΔFEV(1) (0-T min)].
  
  
  RESULTS
  IV montelukast 7 mg was significantly more effective than placebo for the time-weighted average ΔFEV(1) (0-60 minutes) [least squares (LS) mean 0.09 L vs. 0.01 L; p < .05]. IV montelukast 14 mg was also more effective than placebo (LS mean 0.17 L; p < .001). Similar improvements in time-weighted average [ΔFEV(1) (0-T min)] were seen at all time points (all p < .05). Both doses of IV montelukast demonstrated a significant increase in average ΔFEV(1) compared with placebo within 10 minutes of administration (p < .001 to p < .01). The tolerability of IV montelukast was similar to that of placebo.
  
  
  CONCLUSIONS
  IV montelukast was significantly more effective than placebo in the improvement of ΔFEV(1) in Japanese patients, suggesting its role as an adjunctive therapy to existing guideline recommendations.
authors: First Department of Internal Medicine, Showa University School of Medicine, Tokyo, Japan.
authors: Mitsuru
authors: M
authors: Adachi
authors: Hiroyuki
authors: H
authors: Taniguchi
authors: Yuji
authors: Y
authors: Tohda
authors: Yasuyuki
authors: Y
authors: Sano
authors: Takaaki
authors: T
authors: Ishine
authors: Steven S
authors: SS
authors: Smugar
authors: Satoru
authors: S
authors: Hisada
mesh_terms: D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D007262:Infusions, Intravenous; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D013440:Sulfides; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast