Pharmacokinetics and safety of tobramycin administered by the PARI eFlow® rapid nebulizer in cystic fibrosis |
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| Institution: | 1. Service de Pneumologie, CRCM adultes, Hôpital Cochin, Assistance Publique des Hôpitaux de Paris, 75679 Paris Cedex 14, France;2. Clinique des Maladies Respiratoires, Hôpital Albert Calmette, CHRU de Lille, 59037 Lille Cedex, France;3. Adult Cystic Fibrosis Care Centre, Centre Hospitalier Lyon-Sud, Pierre-Bénite Cedex, France;4. Service de Pneumologie-Allergologie, CRCM adulte, Hôpital Larrey, CHRU de Toulouse, 31059 Toulouse Cedex 09, France;5. Centre de Ressources et Compétences pour la Mucoviscidose, Hôpital Renée Sabran, Hospices Civils de Lyon, France;6. Departement of Pneumology and CRCM mixte, Rouen University Hospital, 76031 Rouen Cedex, France;7. Service de Pédiatrie, Hôpital Robert Debré, 75019 Paris, France;8. Novartis Horsham Research Centre, Horsham, West Sussex, UK;9. Novartis Pharma AG, 4002 Basel, Switzerland |
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| Abstract: | BackgroundNebulization times have been identified as an issue in patient compliance with tobramycin solution for inhalation (TSI) therapy in cystic fibrosis (CF).MethodsIn 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.ResultsNebulization 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.ConclusionUse of the eFlow rapid nebulizer reduced TSI nebulization time. The systemic exposure to tobramycin appeared to be broadly similar in this exploratory study. |
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