Pharmacokinetics and safety of tobramycin administered by the PARI eFlow rapid nebulizer in cystic fibrosis.
BACKGROUND
Nebulization times have been identified as an issue in patient compliance with tobramycin solution for inhalation (TSI) therapy in cystic fibrosis (CF).


METHODS
In this randomized, open-label, multicentre, two-period, crossover study, patients (n=25) with CF and chronic pulmonary pseudomonal infection received TSI for 15 days via eFlow rapid or LC PLUS nebulizer. Nebulization times and sputum/serum tobramycin concentrations were determined, and safety evaluated.


RESULTS
Nebulization times were significantly shorter for eFlow rapid versus LC PLUS on Day 1 (least squares mean estimate of the difference -10.5 min, 95% confidence intervals [CI] -12.6, -8.3, p<0.0001) and Day 15 (difference -7.7 min, 95% CI -9.0, -6.5, p<0.0001). Broadly comparable sputum/systemic exposure to tobramycin was observed and the incidence of adverse events was similar for both nebulizers.


CONCLUSIONS
Use of the eFlow rapid nebulizer reduced TSI nebulization time. The systemic exposure to tobramycin appeared to be broadly similar in this exploratory study.
Hubert
Dominique
D
CRCM adultes, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris, France.
Leroy
Sylvie
S
Nove-Josserand
Raphaële
R
Murris-Espin
Marlène
M
Mely
Laurent
L
Dominique
Stéphane
S
Delaisi
Bertrand
B
Kho
Pearl
P
Kovarik
John M
JM
D000280:Administration, Inhalation; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000150:complications*; D005260:Female; D006801:Humans; D008168:Lung / Q000382:microbiology; D008171:Lung Diseases; D008297:Male; D009330:Nebulizers and Vaporizers; D011552:Pseudomonas Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification*; D014031:Tobramycin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D014031:Tobramycin