P. Zanen et al., THE EFFICACY OF A LOW-DOSE, MONODISPERSE PARASYMPATHICOLYTIC AEROSOL COMPARED WITH A STANDARD AEROSOL FROM A METERED-DOSE INHALER, European Journal of Clinical Pharmacology, 54(1), 1998, pp. 27-30
Objective: In previous experiments we showed that monodisperse broncho
dilator aerosols with a median mass aerodynamic diameter of 2.8 mu m i
nduced stronger bronchodilatations than larger aerosols and that the d
ilatations were clinically relevant at low doses. To discover whether
the bronchodilator effects of these low-dose monodisperse aerosols dif
fered from those of standard dosages delivered by metered-dose inhaler
s, we carried out a comparative trial. Methods: Ten stable outpatients
with a mean forced expiratory volume in 1 s (FEV1) of 58.1% of the pr
edicted value inhaled a placebo aerosol, 8 mu g of a 2.8-mu m monodisp
erse ipratropium bromide aerosol and 40 mu g from a metered-dose inhal
er plus spacer; lung-function measurements followed. Data were analyse
d with repeated measurements analysis of variance (ANOVA). Results: Gr
eater improvements than with placebo were evident for the forced vital
capacity (FVC), the FEV1, the specific airway conductance (sGaw), the
peak flow (PEF) and the maximum expiratory flow at 75% of the forced
vital capacity (MEF75). In these cases, the low-dose 2.8-mu m aerosol
proved to be equivalent to the higher-dose metered-dose inhaler. Concl
usion: By changing the polydisperse characteristic of inhaled aerosols
to a monodisperse pattern, the dose of the drug administered can be r
educed without loss of efficacy.