Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 mu g twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma
Ed. Bateman et al., Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 mu g twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma, RESP MED, 95(2), 2001, pp. 136-146
This multi-centre, randomized, double-blind, double-dummy, parallel-group s
tudy was designed to investigate the hypothesis of equivalent efficacy and
comparable safety of two inhaled presentations of salmeterol/fluticasone pr
opionate combination product (SALM/FP) 50/100 mug administered twice daily
to patients with mild-to-moderate asthma for 12 weeks. The delivery systems
were a 25/50 mug strength hydrofluoroalkane (HFA) metered-dose inhaler (MD
I) and a Diskus(TM) inhaler (50/100 mug strength). A third group received F
P 100 mug twice daily via a chlorofluorocarbon MDI (50 mug strength). A tot
al of 497 patients aged 11-79 years with reversible airways obstruction who
were symptomatic on inhaled corticosteroid (ICS) therapy and had room for
improvement in lung function were randomized to treatment in a double-blind
, parallel-group design (SALM/FP MDI: n=165; SALM/FP Diskus(TM): n=167; FP
MDI: n=165) for 12 weeks. A total of 383 patients completed the study accor
ding to the protocol.
According to the primary efficacy variable, increase in mean morning PEF ov
er weeks 1-12, the two inhaled presentations of SALM/FP were clinically equ
ivalent (adjusted mean increases 43 and 46 l min(-1); treatment difference
3 l min(-1); 95% confidence interval: -6 to 11 l min(-1)). Equivalence was
also demonstrated by all secondary efficacy measures. The SALM/FP MDI was s
ignificantly superior to the FP MDI for increase in mean morning PEF (treat
ment difference 19 l min(-1); P < 0.001) and for all secondary measures exc
ept FEV1 and symptom-free nights. There was no significant difference betwe
en the groups with respect to adverse events and serum cortisol levels.
These results demonstrate that the SALM/FP 25/50 <mu>g HFA MDI (two inhalat
ions twice daily) is clinically equivalent to the SALM/FP 50/100 mug Diskus
(TM) (one inhalation twice daily). Patients switching to SALM/FP from other
MDI-based asthma treatments may now do so without a change of delivery dev
ice.