Fluticasone Propionate via Diskus™ Inhaler at Half the Microgram Dose of Budesonide via Turbuhaler™ Inhaler.

Objective: To evaluate the efficacy and tolerability of two inhaled corticosteroid treatment regimens, fluticasone propionate (FP) delivered from a Diskus™ inhaler and budesonide delivered from a Turbuhaler™ inhaler, in adult patients with asthma. Design and Setting: This was an open, randomised, multicentre, parallel group study conducted in nine countries. Patients: 277 patients with asthma, aged 18 to 87 years, with mean baseline forced expiratory volume in 1 second (FEV) 75% predicted and treated with 400 to 1200 µg/day of inhaled corticosteroid, were randomised to treatment. Interventions: 137 patients received FP 250µg twice daily from a Diskus™ inhaler and 140 received budesonide 600µg twice daily from a Turbuhaler™ inhaler for 4 weeks. Results: No significant differences were seen between the two treatments for mean morning peak expiratory flow recorded on a daily record card [95% confidence limit (CL) for difference -5.1, 11.3 L/min, p = 0.46] or for any other efficacy parameter. A significant difference in adjusted geometric mean 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 Diskus™ inhaler over the Turbuhaler™ inhaler; 81% of patients used the Diskus™ inhaler correctly first time compared with 61% for the Turbuhaler™ 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™ inhaler was also generally rated more highly by patients than the Turbuhaler™ inhaler. [ABSTRACT FROM AUTHOR]

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