The choice of compressor effects the aerosol parameters and the delivery of tobramycin from a single model nebulizer.
Recent U.S. Phase III trials of the aerosolized delivery of tobramycin to cystic fibrosis (CF) patients demonstrated a significant improvement in pulmonary function and in sputum bacterial density. These trials used the Pari LC Plus nebulizer and DeVilbiss Pulmo-Aide compressor. This compressor is not generally available in Europe, and its power requirements do not match the European power supply. Thus alternate compressors were evaluated, using the LC Plus nebulizer, in preparation for European clinical trials. Aerosol particle size distribution, nebulization time (min), and the respirable dose of tobramycin (mg within 1-5 mu) were obtained for seven compressor models. The respirable quantity delivered by each of the European compressors (240 Volts, 50 Hz) was compared to the LC Plus and PulmoAide compressor (120 Volts, at 60 Hz). The U.S. system delivered 71.4 mg of the 300 mg instilled dose within the respirable range; using the European compressors, between 63.0 and 74.8 mg was delivered. With a 97% confidence that the delivered tobramycin was within 20% of the standard, we conclude that the SystAm 23ST, MedicAid CR50 and CR60, Pari Master and the Pari Boy compressors are equivalent to the U.S. standard; the Hercules and the SystAm 26ST compressors were not statistically equivalent to the standard. Using the LC Plus nebulizer, five European compressors delivered doses of TOBI that are similar to the doses delivered by the DeVilbiss PulmoAide compressors, and thus may be expected to produce clinical results similar to those of the U.S. trials.
Standaert
T A
TA
Cystic Fibrosis Research Center, Children's Hospital and Medical Center, Seattle, Washington, USA. tasphd@u.washington.edu
Vandevanter
D
D
Ramsey
B W
BW
Vasiljev
M
M
Nardella
P
P
Gmur
D
D
Bredl
C
C
Murphy
A
A
Montgomery
A B
AB
D000336:Aerosols / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D015203:Reproducibility of Results; D014031:Tobramycin / Q000008:administration & dosage*
D000336:Aerosols; D000900:Anti-Bacterial Agents; D014031:Tobramycin