Fluticasone propionate via Diskus (TM) inhaler at half the microgram dose of budesonide via Turbuhaler (TM) inhaler

Objective: To evaluate the efficacy and tolerability of two inhaled cortico steroid treatment regimens, fluticasone propionate (FP) delivered from a Di skus(TM) inhaler and budesonide delivered from a Turbuhaler(TM) inhaler, in adult patients with asthma. Design and Setting: This was an open, randomised, multicentre, parallel gro up study conducted in nine countries. Patients: 277 patients with asthma, aged 18 to 87 years, with mean baseline forced expiratory volume in 1 second (FEV1) 75% predicted and treated with 400 to 1200 mug/day of inhaled corticosteroid, were randomised to treatmen t. Interventions: 137 patients received FP 250 mug twice daily from a Diskus(T M) inhaler and 140 received budesonide 600 mug twice daily from a Turbuhale r(TM) inhaler for 4 weeks. Results: No significant differences were seen between the two treatments fo r mean morning peak expiratory flow recorded on a daily record card [95% co nfidence limit (CL) for difference -5.1, 11.3 L/min, p = 0.46] or for any o ther efficacy parameter. A significant difference in adjusted, geometric me an morning serum cortisol level after 4 weeks' treatment was seen in favour of FP (ratio of FP adjusted mean to budesonide adjusted mean 1.29, 95% CL 1.14, 1.47 nmol/L, p < 0.001). Device handling assessments favoured the Dis kus(TM) inhaler over the Turbuhaler(TM) inhaler; 81% of patients used the D iskus(TM) inhaler correctly first time compared with 61% for the Turbuhaler (TM) inhaler. Conclusions: Administration of FP at less than half the microgram dosage of budesonide was as effective and caused less hypothalamic-pituitary-adrenal axis suppression measured by serum cortisol levels. The Diskus(TM) inhaler was also generally rated more highly by patients than the Turbuhaler(TM) i nhaler.