THE EFFECT OF SALMETEROL ON NOCTURNAL SYMPTOMS, AIRWAY FUNCTION, AND INFLAMMATION IN ASTHMA

Study objective: To determine the efficacy of salmeterol alone in a gr oup of patients with moderate asthma with nocturnal worsening of sympt oms. Design: Double-blind, randomized, placebo-controlled crossover st udy. Setting: Tertiary care hospital specializing in respiratory disea ses. Participants: Ten patients with nocturnal asthma. Interventions: Subjects were randomized to salmeterol, 100 mu g mice daily, or placeb o for 0 weeks with a 1-week washout between treatment periods, Symptom s, nocturnal awakenings, and beta 2-agonist use were recorded daily. S pirometry was performed at weeks 1 and 0 of each period at bedtime and at 4 AM, and methacholine challenge was performed at 4 AM followed by bronchoscopy with BAL, BAL fluid analysis included cell count and dif ferential count, eosinophil cationic protein, Charcot-Leyden crystal p rotein, leukotriene B-4, and thromboxane B-2. Results: The percentage of nights with awakenings decreased significantly with salmeterol (69. 8+/-8.7% vs 30.6+/-10.8% for placebo and salmeterol, respectively; p=0 .02). The percentage of 24-h days with supplemental inhaled beta(2)-ag onist use significantly decreased with salmeterol (85.9+/-9.4% vs 70.4 +/-10.1% for placebo and salmeterol, respectively; p=0.04). There were no significant differences in bronchial reactivity, 4 AM FEV1, overni ght percentage change in FEV1, or indexes of airway inflammation. Conc lusions: Salmeterol alone improves the number of nocturnal awakenings and supplemental 24-h beta(2)-agonist use in nocturnal asthma without significantly altering lung function and airway inflammation.