Mm. Nieminen et al., EASYHALER(R), A NOVEL MULTIPLE-DOSE POWDER INHALER - CLINICALLY EQUIVALENT TO SALBUTAMOL METERED-DOSE INHALER AND EASIER TO USE, Respiration, 61(1), 1994, pp. 37-41
Twenty-one adult asthmatic patients participated in a trial to compare
the clinical equivalence of a single dose of salbutamol inhaled eithe
r from a novel multiple dose powder inhaler (MDPI), Easyhaler(R), or f
rom a conventional metered dose inhaler (MDI). The trial was carried o
ut as a randomized, double-blind, crossover study. The study involved
2 study days with a 6-hour follow-up period of spirometric indices. In
addition, blood pressure and heart rate were measured immediately bef
ore each lung function test. Our data indicate that salbutamol treatme
nt with the MDPI achieves values which are equivalent to those achieve
d with the conventional pressurized MDI as regards improving pulmonary
function and tolerability. The mean maximum forced expiratory volume
in Is (FEV(1)) after the powder dose was 2.44 +/- 0.96 liters and afte
r the aerosol dose 2.45 +/- 0.93 liters. The mean area under the curve
of absolute FEV(1) values was 822 +/- 340 and 829 +/- 335, respective
ly. The mean percent change from the baseline in FEV(1), forced vital
capacity and peak expiratory flow following administration of the prep
arations was of equal magnitude in both cases. The treatments tested h
ad no effect on blood pressure or heart rate and were well tolerated.
A further important finding was that most patients found the MDPI easi
er or no more difficult to use than the conventional MDI and this prob
ably facilitates the transition from pressurized MDIs to the novel MDP
I.