RANDOMIZED TRIAL OF ZILEUTON IN PATIENTS WITH MODERATE ASTHMA - EFFECT OF REDUCED DOSING FREQUENCY AND AMOUNTS ON PULMONARY-FUNCTION AND ASTHMA SYMPTOMS

This 6-month, randomized, multicenter study was designed to determine whether patients who had been treated with the leukotriene pathway inh ibitor zileuton 600 mg four times daily (QID) for 2 months could be ma intained at the same level of pulmonary function, symptom control, and beta-agonist use with less frequent dosing-first 600 or 800 mg three times daily (TID) and then twice daily (BID). A total of 278 patients with chronic asthma, ages 16 to 70, participated at 25 US centers. All had a 1-second forced expiratory volume (FEV1) of 35%-75%, reversible airway disease, and a nonsmoking history of 1 year. An 8-week open-la bel period (zileuton 600 mg QID) was followed by a 16-week double-blin d period, in which patients who responded to the QID treatment were ra ndomized to receive zileuton 600 or 800 mg TID for 8 weeks and then re randomized to receive zileuton 600 or 800 mg BID for another 8 weeks. Primary outcomes were FEV1 and asthma symptom scores; secondary outcom es were peak expiratory flow rate, beta-agonist use, and asthma exacer bations requiring steroid rescue. Patients who showed improvements in lung function when treated with zileuton 600 mg QID demonstrated minim al decreases in FEV1 and comparable peak expiratory flow rates, sympto m control, beta-agonist use, and systemic corticosteroid rescue when b eing treated with lower doses and/or less frequent doses of zileuton. Patients who demonstrate improved asthma control with zileuton 600 mg QID may be able to reduce their daily dosage and/or frequency while st ill maintaining the same level of symptom control.