16 males with stable CF, 8 children and 8 adults, and an FEV(1) > 45% predicted
Interventions
Patients inhaled both preparations (Tobramycin (TOBI(R), 300 mg at 60 mg/ml) inhaled from the PARI LC PLUS(R) nebulizer and 1.5 ml of 100 mg/ml tobramycin solution delivered by an investigational eFlow(R) nebulizer) on two occasions with (99m) Tc-DTPA added to the tobramycin.
Outcome measures
Blood samples were taken for quantification of tobramycin in the serum.
Main results
The PARI LC PLUS(R) delivered 45.4 (39.3-51.6), mean and 95% CI, mg to the lungs in 17.0 +/- 2.5 min (mean +/- SD) with serum levels of 1,089 +/- 388 microg/L. The investigational eFlow(R) delivered 46.3(40.3-51.7) mg in 4.0 +/- 1.0 min with blood levels of 909 +/- 458 microg/L. Only the time of delivery was significantly different with P < 0.0001 (paired t-test). Tolerability of the treatment was comparable for both inhalation regimes, but the shorter treatment was preferred by all patients.
Authors' conclusions
These results demonstrate the possibility of delivering equivalent levels of tobramycin much faster into the lungs of CF patients when using eFlow(R), a very efficient electronic nebulizer.