T. Koskela et al., Equivalence of two steroid-containing inhalers: Easyhaler multidose powderinhaler compared with conventional aerosol with large-volume spacer, RESPIRATION, 67(2), 2000, pp. 194-202
Background and Objectives: An equivalence study was conducted in which the
efficacy and safety of a daily dose of 800 mu g of beclomethasone diproprio
nate administered via a multidose powder inhaler, Easyhaler, and via a mete
red-dose inhaler (MDI) with a large-volume spacer were compared in adult, n
ewly diagnosed, steroid-naive asthmatic patients. Acceptability of the medi
cations was also compared. Methods: One hundred and forty-four patients wer
e recruited into the double-blind, double-dummy, randomised, parallel-group
multicentre study. The study treatment period was 8 weeks. It was preceded
by a 2-week run-in period. Morning and evening peak expiratory flow (PEF),
numbers of inhalations of a sympathomimetic and asthma symptoms were recor
ded daily. Spirometry and histamine challenge were performed, and health-re
lated quality of life and morning serum cortisol levels measured during con
trol visits. Results: Criteria indicating treatment equivalence were met. T
he mean of the primary outcome variable, morning PEF, increased significant
ly, from 426 to 461 litres/min in the Easyhaler group and from 436 to 467 l
itres/min in the MDI+spacer group. Similar improvements between groups were
also seen in relation to all secondary variables. Changes in serum cortiso
l levels were minor. In 6 out of 10 questions about device acceptability, t
he majority of patients rated Easyhaler as better than the MDI+spacer combi
nation, Conclusion: It was concluded that the devices tested were equivalen
t in terms of efficacy and safety. Copyright (C) 2000 S. Karger AG, Basel.