Randomised, placebo controlled trial of effect of a leukotriene receptor antagonist, montelukast, on tapering inhaled corticosteroids in asthmatic patients

Abstract

Objective To determine the ability of montelukast, a leukotriene receptor antagonist, to allow tapering of inhaled corticosteroids in clinically stable asthmatic patients. Design Double blind, randomised, placebo controlled, parallel group study. After a single blind placebo run in period, during which (at most) two inhaled corticosteroids dose decreases occurred, qualifying, clinically stable patients were allocated randomly to receive montelukast (10 mg tablet) or matching placebo once daily at bedtime for up to 12 weeks. Setting 23 academic asthma centres in United States, Canada, and Europe. Participants 226 clinically stable patients with chronic asthma receiving high doses of inhaled corticosteroids (113 randomised to montelukast and 113 to placebo). Interventions Every 2 weeks, the inhaled corticosteroids dose was tapered, maintained, or increased (rescue) based on a standardised clinical score. Main outcome measures Last tolerated dose of inhaled corticosteroids.Results Compared with placebo, montelukast allowed significant (P = 0.046) reduction in the inhaled corticosteroid dose (montelukast 47% v placebo 30%; least square mean difference 17.6%, 95% confidence interval 0.3 to 34.8). Fewer patients on montelukast (18 (16%) v 34 (30%) placebo, P = 0.01) required discontinuation because of failed rescue. Conclusions Montelukast reduces the need for inhaled corticosteroids among patients requiring moderate to high doses of corticosteroid to maintain asthma control.

Administrative Claims Analysis of Asthma-Related Health Care Utilization for Patients Who Received Inhaled Corticosteroids With Either Montelukast or Salmeterol as Combination Therapy

“…The ability to taper ICS dosage when used concomitantly with MON has been demonstrated. 23 Flexibility in dosing allows for convenient step-up in ICS dose, as recommended in the guidelines; this is more difficult with the fixed-dose combination typically used when SAL is chosen as the add-on therapy. The ability to make incremental changes in asthma medication reg- imens allows both physicians and patients to titrate medications as needed to achieve asthma control.…”

Dose reduction of inhaled corticosteroids under concomitant medication with montelukast in patients with asthma

“…Owing to the beneficial effects of antileucotrienes and the efforts to keep steroid doses low, several studies have addressed the extent to which inhaled corticosteroids might be substituted or supplemented by these drugs [14][15][16]. Most of these trials used lung function and symptoms as outcome variables.…”

Distribution of therapeutic response in asthma control between oral montelukast and inhaled beclomethasone

“…Antileukotriene agents, including montelukast, zafirlukast, pranlukast and the 5-lipoxygenase inhibitor zileuton, act by blocking the effects of the cysteinyl leukotrienes. Montelukast is an orally active, potent and specific cysteinyl leukotriene receptor antagonist that has been shown to improve the signs and symptoms of asthma in several placebo-controlled trials of patients with chronic asthma o2 yrs of age [6][7][8][9]. National and international consensus guidelines for treating asthma recommend daily controller therapy for patients with persistent asthma [10,11].…”