FLUTICASONE PROPIONATE COMPARED WITH THEOPHYLLINE FOR MILD-TO-MODERATE ASTHMA

Background: The inhaled corticosteroid, fluticasone propionate, was co mpared with the oral bronchodilator theophylline in the maintenance tr eatment of asthma. Objective: The objective of the present study was t o compare the efficacy and safety of twice-daily inhaled fluticasone p ropionate, 50 mu g, and fluticasone propionate, 100 mu g, with that of theophylline in the maintenance treatment of mild-to-moderate asthma. Methods: In this randomized, double-blind, placebo-controlled, parall el-group study, 353 adult and adolescent patients with asthma inadequa tely controlled with inhaled beta-agonist therapy alone received fluti casone propionate, 50 mu g, or fluticasone propionate, 100 mu g, by me tered-dose inhaler; theophylline capsules; or placebo twice daily for 12 weeks. Only inhaled albuterol was permitted as needed for acute sym ptoms. Results: Both fluticasone propionate groups had a significantly greater probability of remaining in the study (ie, meeting asthma sta bility criteria) than did either the theophylline or placebo group (P less than or equal to .008); 39% and 51% in the theophylline and place bo groups, respectively, were withdrawn due to lack of treatment effic acy compared with 14% and 21% in the fluticasone propionate, 50 mu g, and fluticasone propionate, 100 mu g, groups. Both fluticasone propion ate groups experienced significantly greater improvement in FEV(1) and PEF compared with patients in the theophylline or placebo group (P le ss than or equal to .004), The incidence of potentially drug-related a dverse events was significantly greater in the theophylline group (25% ) than in the placebo group (11%) (P = .031), while there were no diff erences between placebo and fluticasone propionate, 50 mu g, (18%) or fluticasone propionate 100 mu g, (22%). Conclusion: Twice daily treatm ent with inhaled fluticasone propionate 50 mu g or 100 mu g was signif icantly more effective than theophylline in the treatment of mild-to-m oderate asthma.