Abstract
Background: Previous data suggest smoking reduces therapeutic effectiveness in asthma, particularly for corticosteroids (CS) (Lazarus et al. AJRCCM. 2007;175:783-90). This study evaluates montelukast (Mont) 10mg daily and fluticasone propionate (FP) 250μg bid, each compared with placebo (Pbo), in patients with self-reported active smoking (after previous inability to quit) and asthma.
Methods: Patients (ages 18-55 years, with asthma [≥1 year], FEV1 60%-90%predicted, airway reversibility [≥12%], and active smoking [≥0.5 to ≤2 packs/day]) were randomized (after a 3-week, single-blind, placebo run-in) to 1 of 3 parallel, 6-month, double-blind treatment arms. Primary efficacy endpoint was Percent of days with Asthma Control (%days-AC) during treatment; AC was defined as a composite: β-agonist (SABA) ≤2 puffs/day, no nighttime symptoms (N-Sxs), and no unscheduled healthcare (U-Hc) or systemic-CS use. Adverse events (AEs) were also evaluated.
Results: The%days-AC over 6 months of treatment was 45% (Mont [N=347]), 49% (FP [N=336]) and 39% (Pbo [N=336]); p-values for Mont and FP (each vs Pbo) were p<0.05 and p<0.001, respectively. The difference between Mont and FP was not significant (p=0.14). Components of%days-AC (SABA and N-Sxs) also showed significant differences from Pbo, but Asthma Attacks (defined as U-Hc or systemic-CS use) were infrequent and not significantly different. AEs occurred in similar proportions among treatment groups.
Conclusion: In a population of asthmatic patients actively smoking cigarettes, both montelukast 10mg daily and fluticasone 250μg bid significantly increased the percent of days with asthma control, compared with placebo.
- © 2011 ERS