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Objective:The aim of this study was to evaluate the oral steroid-sparing capacity of budesonide Turbuhaler®. Methodology:One hundred and thirteen oral steroid-dependent patients were treated for 6 months with placebo or budesonide 800 μg or 1600 μg daily. Every second week the oral steroid dose was reduced if asthma control permitted. Results:The reductions in oral steroid doses were 9, 35 and 60% in the placebo and budesonide 800 μg and 1600 μg groups, respectively. Oral steroid treatment could be discontinued in 4% (placebo), 15% (800 μg) and 23% (1600 μg). Mean peak expiratory flow values increased by 21 and 24 L/min in the budesonide groups but decreased by 6 L/min in the placebo group. Asthma attack, activity and sleep scores remained unchanged showing maintained efficacy. Plasma cortisol levels increased and an adrenocorticotropic hormone test showed improved adrenocortical response in both budesonide groups, indicating improved safety. Adverse drug reactions were infrequent and mild in all study groups. Conclusion:Budesonide Turbuhaler, 800 μg and 1600 μg daily, resulted in a significant reduction in oral steroid usage in steroid-dependent patients. The effect was achieved with maintained asthma control together with improvements in lung and adrenal functions. [ABSTRACT FROM AUTHOR]

Objective:The aim of this study was to investigate the dose–response for inhaled budesonide via Turbuhaler® in Japanese patients with mild to moderate asthma. Methodology:Inhaled budesonide 100 μg, 200 μg, 400 μg or placebo was administered twice daily via Turbuhaler for 6 weeks, to 267 adult Japanese patients (mean age 51 years) with mild-to-moderate, non-steroid-dependent bronchial asthma, in a double-blind, placebo-controlled, randomized, parallel group study. The patients had to be symptomatic for more than 3 days/week and have an average morning peak expiratory flow (PEF) 50–80% of predicted normal value. Results:The response to budesonide was rapid, all treatments showing a significant improvement in morning PEF after 1 week (P < 0.05). During week 6, mean improvements of 15, 45, 53 and 71 L/min were observed for the placebo, 200 μg, 400 μg and 800 μg budesonide groups, respectively. Compared with placebo all improvements in the budesonide groups were statistically significant and a significant dose–response was demonstrated (P < 0.001). The difference between the 200 μg and 800 μg doses was significant. Also, for several secondary efficacy variables (e.g. evening PEF, symptom score, treatment score, daily activity score and sleep score) significant dose–responses were shown. Other variables included the investigators’ assessments of improvement and usefulness. They also showed statistically significant dose–response relationships and confirmed the rapid onset of action. Budesonide was well tolerated at all tested doses, with a low incidence of adverse events, all of which were minor in severity. Conclusions:Budesonide Turbuhaler in the doses 100 μg to 400 μg twice daily was effective, well tolerated and showed a rapid onset of action in patients with mild-to-moderate asthma. Dose–response was demonstrated for several variables of clinical efficacy. [ABSTRACT FROM AUTHOR]