Equivalence of two steroid-containing inhalers: easyhaler multidose powder inhaler compared with conventional aerosol with large-volume spacer.
OBJECTIVE
An equivalence study was conducted in which the efficacy and safety of a daily dose of 800 microgram of beclomethasone diproprionate administered via a multidose powder inhaler, Easyhaler, and via a metered-dose inhaler (MDI) with a large-volume spacer were compared in adult, newly diagnosed, steroid-naive asthmatic patients. Acceptability of the medications was also compared.


METHODS
One hundred and forty-four patients were 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 recorded daily. Spirometry and histamine challenge were performed, and health-related quality of life and morning serum cortisol levels measured during control visits.


RESULTS
Criteria indicating treatment equivalence were met. The mean of the primary outcome variable, morning PEF, increased significantly, from 426 to 461 litres/min in the Easyhaler group and from 436 to 467 litres/min in the MDI+spacer group. Similar improvements between groups were also seen in relation to all secondary variables. Changes in serum cortisol levels were minor. In 6 out of 10 questions about device acceptability, the majority of patients rated Easyhaler as better than the MDI+spacer combination.


CONCLUSIONS
It was concluded that the devices tested were equivalent in terms of efficacy and safety.
Koskela
T
T
Orion Pharma, Kuopio, Finland. tommi.koskela@orion.fi
Hedman
J
J
Ekroos
H
H
Kauppinen
R
R
Leinonen
M
M
Silvasti
M
M
Tukiainen
H
H
D000280:Administration, Inhalation; D000328:Adult; D000336:Aerosols; D001249:Asthma / Q000097:blood / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004304:Dosage Forms; D004311:Double-Blind Method; D004869:Equipment Safety; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D010349:Patient Compliance; D011208:Powders; D011788:Quality of Life; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D000336:Aerosols; D004304:Dosage Forms; D011208:Powders; D001507:Beclomethasone; D006854:Hydrocortisone