A STUDY ON THE CLINICAL EQUIVALENCE AND PATIENT PREFERENCE OF FLUTICASONE PROPIONATE 250 MU-G TWICE-DAILY VIA THE DISKUS(TM) ACCUHALER(TM) INHALER OR THE DISKHALER(TM) INHALER IN ADULT ASTHMATIC-PATIENTS/

The Diskus(TM)/Accuhaler(TM) inhaler (D/A) is a new multidose powder i nhaler, designed to deliver all asthma drugs. This study was carried o ut to establish clinical equivalence between FP 250 mu g twice daily ( b.i.d.) via the D/A and FP 250 mu g b.i.d. via the current powder inha ler, the Diskhaler (DH). Also, device handling and patient preference for both devices were determined. This was a multicenter, randomized, double-blind, double-dummy, parallel-group study. Adult asthmatics (36 4, aged 18-79) requiring inhaled corticosteroids in a daily dosage of 400 mu g up to and including 1000 mu g and demonstrating a mean mornin g peak expiratory flow rate (PEFR) calculated from the last 7 days of the run-in of less than 85% of the response after salbutamol, a baseli ne forced expiratory volume in 1 sec (FEV1) between 50 and 90% of thei r predicted normal value, and an ability to correctly use both devices , were randomized to a 12-week treatment period. No statistically sign ificant differences between the two devices were seen for mean morning PEFR (p = 0.76), mean evening PEFR (p = 0.88), median daytime and nig httime symptom score (p = 0.57 and p = 0.47), median percentage of res cue-free days and nights (p = 0.43 and p = 0.24), and clinic visit lun g function. No differences in the safety profile of FP were seen. Pati ents found the D/A easier to use and easier with respect to assessing the number of doses remaining (both p < 0.001). Sixty-five percent of the patients expressed an overall preference for the D/A over the DH ( p < 0.001). The results show that FP 250 mu g b.i.d. via the D/A is cl inically equivalent to delivery via the DH. Both treatments proved to be equally safe and were well tolerated. The D/A was easier to use and patients preferred the DIA over the DH.