Use of montelukast in tapering inhaled corticosteroid therapy: An open-label, 48-week trial

Background: International asthma treatment guidelines recommend tapering inhaled corticosteroid (ICS) therapy to the lowest dose that provides the maximum effect. Montelukast, a leukotriene receptor antagonist with complementary anti-inflammatory actions, has been shown in a tightly controlled trial to allow effective tapering of ICS therapy.

Objectives: The purpose of this naturalistic study was to assess whether administration of montelukast could assist in the tapering of ICS therapy in patients with established asthma and whether the reduced dose achieved at 12 weeks could be maintained at 48 weeks without loss of asthma control.

Methods: Patients with proven chronic asthma who were being treated with moderate to high doses of ICS (beclomethasone equivalent of 600 to 3200 mug/d) and required, according to their physician, the prescribed dose to maintain asthma control, were given open-label oral montelukast (10 mg/d at bedtime) for 48 weeks. Patients who were clinically, stable, based on a composite clinical performance score, had their ICS dose reduced by similar to 25% at 2-week intervals for 12 weeks and at 6-week intervals for the remaining 36 weeks. The percentage reduction in final ICS dose associated with clinical stability was the primary end point of the study.

Results: Five hundred eighty-one patients were enrolled (57% female; mean age, 41 years). At 12 weeks, the mean ICS dose had been tapered by 82.3% (from 959 mug/d to 172 mug/d) and a total of 345 patients (59.5%) had completely stopped ICS. At 48 weeks, mean ICS dose had been tapered by 81.3% (from 959 mug/d to 178 mug/d; P < 0.001), and 356 patients (61.3%) had completely stopped ICS. During tapering, patients remained clinically stable despite a significant similar to 30% reduction in beta-agonist use (P < 0.001). There was a small but significant 2.7% decrease in forced expiratory volume in 1 second (P < 0.001). The extent of tapering was similar regardless of the ICS used (fluticasone, budesonide, beclomethasone, or flunisolide) and independent of baseline beta-agonist use. Montelukast was generally well tolerated. Fifty-one patients (9%) discontinued due to clinical adverse events.

Conclusion: In patients with chronic asthma treated with ICS, the addition of montelukast to assist in ICS tapering can be applied in clinical practice without loss of asthma control.