Administration of budesonide once daily by means of Turbuhaler to subjects with stable asthma

Background: Optimal management of chronic, mild-to-moderate asthma with inhaled 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 steroids must be rigorously evaluated in controlled clinical trials. Objectives: The objective of this study was to assess the efficacy and safety of once daily treatment with budesonide in subjects with stable asthma. Methods: Once daily budesonide was assessed in 309 adult subjects, including those who were and were not using an inhaled steroid at baseline. The subjects were stratified by inhaled steroid use and randomly assigned to one of 3 treatments: 200 μg budesonide, 400 μg budesonide, or placebo administered by means of Turbuhaler once daily in the morning for 6 weeks. Beyond this point, treatment was continued unchanged for another 12 weeks (maintenance) in those receiving 200 μg budesonide once daily and placebo. In those who received 400 μg budesonide once daily, the dose was reduced to 200 μg once daily at week 6 and held constant for the remaining 12 weeks (400/200 μg group). Primary efficacy endpoints were mean change from baseline in FEV 1 and morning peak expiratory flow. Results: Once daily budesonide was well tolerated and resulted in significant improvements in all efficacy endpoints, even though baselines were well stabilized. Baseline lung function was elevated with little room for improvement; however, mean increases in FEV 1 during the maintenance period were 0.10 L and 0.11 L in the 200 μg and 400/200 μg groups, respectively, versus a decrease of –0.09 L in the placebo arm ( P < .001). Results for peak expiratory flow were similar. Significant improvements in secondary endpoints, including symptoms, β-agonist use, and quality of life, also developed with budesonide 200 and 400 μg once daily. Conclusion: Inhaled budesonide, in doses as low as 200 μg, may be an appropriate introductory or maintenance dose in subjects with stable, mild-to-moderate asthma. (J Allergy Clin Immunol 1999;104:46-52.)