Abstract
In a two-stage detection program, subjects with signs of obstructive airway disease were selected from a random sample of the general population. Subjects (n = 82) were randomly assigned to either fluticasone propionate 250 microg twice a day or placebo twice a day via pMDI in a 1-yr, double-blind trial if they met criteria for persistent airway obstruction, increased bronchial hyperresponsiveness, or a rapid decline in FEV(1). Main outcome measures were postbronchodilator FEV(1), quality-adjusted life years (QALYs), and direct medical cost. Secondary measures were prebronchodilator FEV(1), PC(20), health-related quality of life (CRQ), symptom-free weeks, episode-free weeks, exacerbations, and indirect cost. Subgroup analysis was based on reversibility of obstruction. Analysis revealed a significant gain in postbronchodilator FEV(1) (98 ml/yr; p = 0.01) in favor of fluticasone. Only subjects with reversible obstruction showed an improvement in PC(20) (1.4 doubling dose; p = 0.03). Early treatment resulted in 2.7 QALYs gained per 100 treated subjects (p = 0.17) and in a clinically relevant improvement in dyspnea (CRQ; p < 0.03). The incremental cost effectiveness ratios were US$13,016/QALY for early treatment and US$33,921/QALY for the combination of detection and treatment. The incremental cost for one additional subject with a clinically relevant difference in dyspnea was US$1,674. In conclusion, early intervention with fluticasone resulted in significant health gains at relatively low financial cost.
