Administration of budesonide once daily by means of Turbuhaler to subjectswith stable asthma

Background: Optimal management of chronic, mild-to-moderate asthma with inh aled steroids may include use of the lowest possible doses, as recommended in guidelines, and a reduction in the frequency of daily administration for greater convenience. Lower doses and once daily treatment with inhaled ste roids must be rigorously evaluated in controlled clinical trials. Objectives: The objective of this study was to assess the efficacy and safe ty of once daily treatment with budesonide in subjects with stable asthma, Methods: Once daily budesonide was assessed in 309 adult subjects, includin g those who were and were not using an inhaled steroid at baseline, The sub jects were stratified by inhaled steroid use and randomly assigned to one o f 3 treatments: 200 mu g budesonide, 400 mu g budesonide, or placebo admini stered by means of Turbuhaler once daily in the morning for 6 weeks. Beyond this point, treatment was continued unchanged for another 12 weeks (mainte nance) in those receiving 200 mu g budesonide once daily and placebo. In th ose who received 400 mu g budesonide once daily, the dose was reduced to 20 0 mu g once daily at week 6 and held constant for the remaining 12 weeks (4 00/200 mu g group). Primary efficacy endpoints were mean change from baseli ne in FEV1 and morning peak expiratory flow. Results: Once daily budesonide was well tolerated and resulted in significa nt improvements in all efficacy endpoints, even though baselines were well stabilized. Baseline lung function was elevated with little room for improv ement; however, mean increases in FEV1 during the maintenance period were 0 .10 L and 0.11 L in the 200 mu g and 400/200 mu g groups, respectively, ver sus a decrease of -0.09 L in the placebo arm (P <.001). Results for peak ex piratory flow were similar. Significant improvements in secondary endpoints , including symptoms, beta-agonist use, and quality of life, also developed with budesonide 200 and 400 mu g once daily. Conclusion: Inhaled budesonide, in doses as low as 200 mu g, may be an appr opriate introductory or maintenance dose in subjects with stable, mild-to-m oderate asthma.