Journal of Cystic Fibrosis
Volume 8, Issue 5 , Pages 332-337, September 2009

Pharmacokinetics and safety of tobramycin administered by the PARI eFlow® rapid nebulizer in cystic fibrosis☆

  • Dominique Hubert

      Affiliations

    • Service de Pneumologie, CRCM adultes, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris, 75679 Paris Cedex 14, France
    • ,
  • Sylvie Leroy

      Affiliations

    • Clinique des Maladies Respiratoires, Hôpital Albert Calmette, CHRU de Lille, 59037 Lille Cedex, France
    • ,
  • Raphaële Nove-Josserand

      Affiliations

    • Adult Cystic Fibrosis Care Centre, Centre Hospitalier Lyon-Sud, Pierre-Bénite Cedex, France
    • ,
  • Marlène Murris-Espin

      Affiliations

    • Service de Pneumologie-Allergologie, CRCM adulte, Hôpital Larrey, CHRU de Toulouse, 31059 Toulouse Cedex 09, France
    • ,
  • Laurent Mely

      Affiliations

    • Centre de Ressources et Compétences pour la Mucoviscidose, Hôpital Renée Sabran, Hospices Civils de Lyon, France
    • ,
  • Stéphane Dominique

      Affiliations

    • Departement of Pneumology and CRCM mixte, Rouen University Hospital, 76031 Rouen Cedex, France
    • ,
  • Bertrand Delaisi

      Affiliations

    • Service de Pédiatrie, Hôpital Robert Debré, 75019 Paris, France
    • ,
  • Pearl Kho

      Affiliations

    • Novartis Horsham Research Centre, Horsham, West Sussex, UK
    • Corresponding Author InformationCorresponding author. Tel.: +44 1403 324658; fax: +44 1403 323060.
    • ,
  • John M Kovarik

      Affiliations

    • Novartis Pharma AG, 4002 Basel, Switzerland

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.

Keywords: Tobramycin solution for inhalation, Cystic fibrosis, Chronic infection, Nebulization, Pharmacokinetics, Pseudomonas aeruginosa

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☆ 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.

PII: S1569-1993(09)00091-5

doi:10.1016/j.jcf.2009.07.001

Journal of Cystic Fibrosis
Volume 8, Issue 5 , Pages 332-337, September 2009

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