title: Leukotriene antagonist prevents exacerbation of asthma during reduction of high-dose inhaled corticosteroid. The Tokyo Joshi-Idai Asthma Research Group.
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.
authors.affiliation: First Department of Medicine, Tokyo Women's Medical College, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Tamaoki
authors.forename: M
authors.initials: M
authors.lastname: Kondo
authors.forename: N
authors.initials: N
authors.lastname: Sakai
authors.forename: J
authors.initials: J
authors.lastname: Nakata
authors.forename: H
authors.initials: H
authors.lastname: Takemura
authors.forename: A
authors.initials: A
authors.lastname: Nagai
authors.forename: T
authors.initials: T
authors.lastname: Takizawa
authors.forename: K
authors.initials: K
authors.lastname: Konno
mesh_terms: D000280:Administration, Inhalation; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000139:chemically induced / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D002867:Chromones / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D020024:Leukotriene Antagonists; D008297:Male; D008875:Middle Aged; D017265:Procaterol / Q000627:therapeutic use; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control
chemical_list: D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D002867:Chromones; D005938:Glucocorticoids; D020024:Leukotriene Antagonists; D001507:Beclomethasone; C047681:pranlukast; D017265:Procaterol