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 ,Revised 25 June 2009 ,Accepted 1 July 2009.

References 

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  2. Hagerman JK, Hancock KE, Klepser ME. Aerosolised antibiotics: a critical appraisal of their use. Expert Opin Drug Deliv. 2006;3:71–86
  3. Cheer SM, Waugh J, Noble S. Inhaled tobramycin (TOBI®): a review of its use in the management of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Drugs. 2003;63:2501–2520
  4. Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Engl J Med. 1999;340:23–30
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  9. Geller DE, Rosenfeld M, Waltz DA, Wilmott RW AeroDose TOBI Study Group. Efficiency of pulmonary administration of tobramycin solution for inhalation in cystic fibrosis using an improved drug delivery system. Chest. 2003;123:28–36
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  15. Westerman EM, De Boer AH, Touw DJ, Le Brun P, Roldaan AC, Frijlink HW, et al. Aerosolization of tobramycin (TOBI) with PARI LC PLUS reusable nebulizer: which compressor to use?. J Aersol Med Pulm Drug Deliv. 2008;21:269–280
  16. United States Food and Drug Administration . Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products, general considerations. 2003;Available at http://www.fda.gov/cder/guidance/index.htm, last accessed on April 23 2009
  17. Burkhardt O, Lehmann C, Madabushi R, Kumar V, Derendorf H, Welte T. Once-daily tobramycin in cystic fibrosis: better for clinical outcome than thrice-daily tobramycin but more resistance development?. J Antimicrob Chemother. 2006;58:822–829
  18. LiPuma JJ. Microbiological and immunologic considerations with aerosolized drug delivery. Chest. 2001;120:118–123

☆ 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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