Pharmacokinetics and safety of tobramycin administered by the PARI eFlow® rapid nebulizer in cystic fibrosis☆
Received 19 October 2008; received in revised form 25 June 2009; accepted 1 July 2009.
Abstract
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.
Conclusion
Use of the eFlow rapid nebulizer reduced TSI nebulization time. The systemic exposure to tobramycin appeared to be broadly similar in this exploratory study.
☆ Previous presentation of data. A summary of the results of this trial have been posted to the Novartis Clinical Trial Results Database. The data have been presented previously as a poster at the 30th European Cystic Fibrosis Conference (ECFC), 13–16 June 2007, Belek, Turkey.
ABSTRACT