Leukotriene antagonist prevents exacerbation of asthma during reduction of high-dose inhaled corticosteroid. The Tokyo Joshi-Idai Asthma Research Group

Am J Respir Crit Care Med. 1997 Apr;155(4):1235-40. doi: 10.1164/ajrccm.155.4.9105060.

Abstract

To test whether the leukotriene antagonist ONO-1078 (pranlukast) prevents asthma exacerbations during reduction of high-dose inhaled corticosteroid, we conducted a randomized, double-blind, placebo-controlled study in 79 asthma patients requiring high doses (1,500 microg/d or more) of inhaled beclomethasone dipropionate (BDI) for clinical control (duration of asthma, 11.0 +/- 3.1 yr; duration of BDI treatment, 0.5 +/- 0.3 yr; FEV1 percentage of predicted, 80.7 +/- 2.0%). After a 2-wk run-in period, the doses of BDI were halved, while the patients were assigned to receive orally ONO-1078, 450 mg twice daily, or placebo. In the placebo group FEV1 decreased by 0.33 +/- 0.20 L after 6 wk (p < 0.001). Likewise, morning and evening PEF decreased by 46 +/- 7 L/min and 18 +/- 6 L/min, respectively. By contrast these variables were sustained above baseline in the ONO-1078 group. The number of daytime and nighttime asthma symptoms and the use of beta2-agonist increased in the placebo group, whereas they remained unchanged in the ONO-1078 group. In the placebo group concentrations of serum eosinophil cationic protein and exhaled nitric oxide increased (p = 0.007 and p = 0.025, respectively), compared with no change in the ONO-1078 group. Therefore, the leukotriene antagonist ONO-1078 prevents the asthma deterioration provoked by a 6-wk reduction of the dose of inhaled BDI into half.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-Agonists / therapeutic use
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / chemically induced
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Beclomethasone / administration & dosage*
  • Beclomethasone / adverse effects
  • Chromones / therapeutic use*
  • Double-Blind Method
  • Female
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / adverse effects
  • Humans
  • Leukotriene Antagonists*
  • Male
  • Middle Aged
  • Procaterol / therapeutic use
  • Substance Withdrawal Syndrome / prevention & control

Substances

  • Adrenergic beta-Agonists
  • Anti-Asthmatic Agents
  • Chromones
  • Glucocorticoids
  • Leukotriene Antagonists
  • Beclomethasone
  • pranlukast
  • Procaterol