INITIAL LOADING (400 μg TWICE DAILY) VERSUS STATIC (400 μg NOCTE) DOSE BUDESONIDE FOR ASTHMA MANAGEMENT

Abstract

SUMMARY This double‐blind study aimed to determine whether superior asthma control is achieved with budesonide (Pulmicort® Turbohaler®) at a loading dose (LD) (400 μg b.d.) for 6 weeks, followed by step down to 400 μg nocte for 12 weeks, compared with a static dose (SD) (400 μg nocte) for 18 weeks. A total of 682 patients (mean peak expiratory flow rate (PEFR) 413 l/min), who demonstrated ≥15% reversibility in PEFR, were randomised into the study. After 18 weeks, patients experienced improvements in morning PEFR (+45 l/min, both groups), symptom score (LD ‐0.57, SD ‐0.49, on a scale of 0‐3), sleep disturbance (LD ‐1.21 nights/week, SD ‐1.06 nights/week) and to‐agonist use (LD ‐1.36 puffs/day, SD ‐1.06 puffs/day), within both groups (each p=0.0001). At 18 weeks, 82% (LD) and 84% (SD) of patients benefited from no nocturnal wakening in the previous 7 days. Overall, at 18 weeks, asthma control was not significantly different between the groups. After 6 weeks, improvements in morning PEFR (LD +36 l/min, SD +26 l/min) and β2‐agonist use (LD ‐1.10 puffs/day, SD ‐0.94 puffs/day) were greater in the loading dose than in the static dose group (each p<0.05). The greater improvement in morning PEFR in the loading dose group was significant by day 7 (p<0.05). While both regimens are equally effective in achieving asthma control at 18 weeks, early clinical advantage is gained with initial loading dose budesonide (400 μg b.d.).