The aims of this study were to assess and compare dose delivery and dose va
riability of pressurized metered dose inhalers (pMDI)/spacers in wheezy inf
ants in daily life and to investigate factors influencing aerosol delivery.
In an open randomized crossover study in 25 wheezy infants aged 5-26 months
, a metal spacer (Nebuchamber(R)), a detergent coated (DC) and a non-deterg
ent coated (nonDC) plastic spacer (Babyhaler(R)) were tested at home for 7
days each. Budesonide (200 mug b.i.d.) was administered via a Nebuchamber o
r fluticasone (125 mug b.i.d.) via a Babyhaler. Aerosol was trapped in filt
ers, positioned between the spacer and face mask. Cooperation was scored on
diary cards. Electrostatic charge (ESC) of the spacers was measured. Evalu
ations of the administration technique were made from video recordings.
Median (range) dose delivery of the filters expressed as per cent (%) of no
minal dose, was 34% (3-59), 23% (1-49), and 41% (12-55) for the Nebuchamber
, nonDC-Babyhaler, and DC-Babyhaler respectively. Considerable dose variabi
lity was found, median (range) within-subject dose variability, expressed a
s coefficient of variation, for the Nebuchamber (49% (15-249)) was signific
antly higher when compared,vith both nonDC- (36% (12-325)) and DC-Babyhaler
s (27% (10-122)), for which dose variabilities were similar.
Detergent coating was effective to reduce electrostatic charge, and to incr
ease dose delivery, but had no effect on dose variability. Bad cooperation
was an important cause for high dose variability for all spacers (r=0.5-0.6
, p<0.02). Many mistakes were made during the administration procedure.