Greater improvement in asthma control with fluticasone propionate than with either zafirlukast or placebo

Purpose: To compare the efficacy of low-dose fluticasone propionate vs zafirlukast in patients who were uncontrolled on short-acting beta-agonists alone. Methods: Two 12-week, randomized, double-blind, placebo-controlled, parallel-group studies were conducted evaluating fluticasone propionate (FP; 88mcg BID) and zafirlukast (ZAF, 20mg BID). Study patients were males and females 5: 12 years of age, FEV₁ = 50-80% of predicted normal who reversed ≥ 12%, and were symptomatic while on short-acting beta-agonists only. Patients were evaluated at 8 clinic visits during the 12-week study, and daily diary card data were collected throughout the study. Clinic FEV₁ measurements and daily PEF, asthma symptoms, nighttime awakenings, and albuterol use data were collected. Results: MEAN CHANGE FROM BASELINE FP (n=214) ZAF (n = 219) PL (n = 229) FEV₁ (L) 0.50*+ 0.32 0.25 AM PEF (L/Min) 40.8*+ 16.7 8.8 PM PEF (L/Min) 32.1*+ 17.1 11.5 Albuterol Use (puffs/day) -2.7*+ -2.0* -1.4 Rescue-Free Days (%) 42.1** 34.9* 21.2 Nighttime Awakenings (no./night) -0.35** -0.27* -0.19 Symptom Scores -0.65*+ -0.39 -0.47 Symptom Free Days (%) 25.0** 15.7* 8.3 *p ≤ 0.05 vs. placebo; ** p ≤ 0.05 vs. placebo and zafirlukast; *+ p≤ 0.001 vs. placebo and zafirlukast Conclusions: In this study evaluating patients who were currently uncontrolled with short-acting beta-agonists alone, treatment with this low dose of FP (88mcg BID) significantly increased all efficacy measurements as compared with either zafirlukast (20mg BID) or placebo. Clinical Implications: These results support the NIH guidelines that inhaled corticosteroids are the preferred first line maintenance treatment for persistent asthma.