HIGH-DOSE FLUTICASONE PROPIONATE, 1 MG DAILY, VERSUS FLUTICASONE PROPIONATE, 2 MG DAILY, OR BUDESONIDE, 1.6 MG DAILY, IN PATIENTS WITH CHRONIC SEVERE ASTHMA

Airway inflammation is now regarded as fundamental in the pathogenesis of asthma and treatment with inhaled corticosteroids has proved effec tive, There is a need for drugs in this category with higher topical p otency but fewer side-effects than those presently available. A double -blind, parallel group study was conducted in 671 patients with severe asthma (already taking between 0.8-2.0 mg of inhaled corticosteroid d aily) to compare the safety and efficacy of 6 weeks of treatment with inhaled fluticasone propionate (FP), 1 mg daily, to fluticasone propio nate, 2 mg daily, and budesonide (BUD), 1.6 mg daily, delivered via a metered-dose inhaler, Peak expiratory flow (PEF), asthma symptoms, and usage of rescue medication were recorded daily by the patient. At eac h clinic visit (-2, 0, 3 and 6 weeks) morning serum cortisol levels, b one markers and spirometry were assessed. The changes in mean morning PEF from baseline (weeks 1-6) were: FP 2 mg daily +24 l . min(-1); FP 1 mg daily +21 l . min(-1); BUD 1.6 mg daily +13 l . min(-1). A simila r rank order for the three treatments was seen for evening PEF, clinic spirometry, reduction of diurnal PEF variation, symptom scores, and r equirement for rescue bronchodilators. The mean serum cortisol levels remained well within the normal range in all three groups, Analysis of the geometric mean cortisol ratio (treatment/baseline ratio after 6 w eeks treatment) showed a changed rank order, the values being: FP 1 mg daily 1.04; BUD 1.6 mg daily 0.97; FP 2 mg daily 0.88, These data sho w that mg for mg, fluticasone propionate is more effective than budeso nide in the treatment of patients with severe asthma.