Adjustable maintenance dosing with budesonide/formoterol or budesonide: Double-blind study

SummaryAdjustable maintenance dosing with either budesonide/formoterol or budesonide was compared in asthma patients.This double-blind trial randomized 133 patients (mean forced expiratory volume in 1 s 66% predicted) to receive 2 inhalations twice daily of budesonide/formoterol 160/4.5 μg (640/18 μg/day) or budesonide 320 μg (1280 μg/day) for 4 weeks. The study drug was adjusted in both groups according to symptoms to 2–4 inhalations daily during Weeks 5–8 and 1–4 inhalations daily during Weeks 9–20.Asthma was well controlled in both groups, with minimal levels of treatment failure (5 budesonide/formoterol vs. 2 budesonide patients; P=NSP=NS) and minimal use of reliever therapy. Clinically important improvements in health-related quality of life (HRQL) occurred in the physical functioning and emotional role functioning domains (both P<0.05P<0.05) for the budesonide/formoterol group compared with budesonide. Physician and patient treatment satisfaction favored budesonide/formoterol (both P<0.05P<0.05). Budesonide/formoterol patients used fewer daily inhalations of study drug (P=0.024P=0.024). The median average daily inhaled corticosteroid dose during the study was 448 μg with budesonide/formoterol and 1152 μg with budesonide.Adjustable maintenance dosing with budesonide/formoterol and budesonide resulted in high levels of asthma control. Adjustable budesonide/formoterol treatment achieved greater HRQL benefits and patient satisfaction, with lower overall drug use.