The currently available facemask interface for the Nebuchamber (N) valved-holding chamber (VHC) provides a very poor seal to the face, which, on average, decreases the aerosol dose and was previously shown to increase the variability of aerosol delivery. The efficiency of a redesigned mask (RD) for the Nebuchamber with a potentially better seal was compared to the standard mask (SM) supplied with the N in a randomized real-life crossover clinical trial. Twenty children (mean age, 26 +/- 10 months) were randomized to use the Nebuchamber for 1 week with the old mask and then for another week with the newer mask, and vice versa. Filters, changed daily, inserted between the mask and the VHC, trapped the delivered drug (budesonide). The dose of budesonide was quantified by high-performance liquid chromatography (HPLC). Use of the redesigned mask improved aerosol delivery to the filter by 30%, compared to the SM (mean 28.1 +/- 7.7% of nominal dose with RD vs. 21.6 +/- 9.6% with SM, P = 0.017). The relatively high within-subject variability in aerosol delivery (36-38%) did not change, however. Facemasks are arguably the most important determinants of aerosol delivery. The newly developed RD for the Nebuchamber proved to be considerably more efficient than the SM for aerosol delivery to young children. Patient-related factors may be more important with respect to the variability observed.
Copyright 2004 Wiley-Liss, Inc.