Budesonide Turbuhaler delivered once daily improves health-related quality of life and maintains improvements with a stepped-down dose in adults with mild to moderate asthma

dBackground: Budesonide inhalation powder administered via Turbuhaler (budesonide Turbuhaler, AstraZeneca LP, Wilmington, DE) is proven efficacious and safe in the treatment of mild to severe asthma. Objective: To evaluate the effect of once-daily budesonide Turbuhaler on health-related quality of life (HRQL) in adults with mild to moderate asthma. Methods: In this double-blind, parallel-group study, 309 asthmatic patients between 18 and 70 years of age were randomized to receive once-daily treatment with budesonide 200 or 400 mug or placebo for 6 weeks. Patients initially receiving 400 mug budesonide had their dose reduced to 200 mug (400/200-mug group), and patients receiving 200 mukg (200/200-mug group) or placebo continued to receive their assigned doses for a 12-week maintenance phase. HRQL was evaluated using the Asthma Quality of Life Questionnaire at randomization, week 6, and week 18. Results: Compared with placebo, patients initially receiving 400 and 200 mug budesonide Turbuhaler demonstrated significantly greater HRQL scores at week 6 (P less than or equal to 0.001 and P less than or equal to 0.010, respectively) that were maintained at week 18 (P less than or equal to 0.001). Clinically important ( greater than or equal to 0.5 unit) improvement in Asthma Quality of Life Questionnaire overall at week 18 was demonstrated by 55% and 43% of patients in the 400/200-mug and 200/200-mug budesonide Turbuhaler groups, respectively. Conclusions: In patients with mild to moderate asthma, once-daily budesonide Turbuhaler 200 and 400 mug demonstrates statistically significant and clinically important improvements in HRQL that can be maintained with a low dose of 200 mug.