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Randomized Controlled Trial Multicenter Study
Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.
- Michael W Konstan, Patrick A Flume, Matthias Kappler, Raphaël Chiron, Mark Higgins, Florian Brockhaus, Jie Zhang, Gerhild Angyalosi, Ellie He, and David E Geller.
- Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH, USA. michael.konstan@UHhospitals.org
- J. Cyst. Fibros. 2011 Jan 1; 10 (1): 54-61.
BackgroundA light-porous-particle, dry-powder formulation of tobramycin was developed, using PulmoSphere® technology, to improve airway delivery efficiency, substantially reduce delivery time, and improve patient convenience and satisfaction. We evaluated the safety, efficacy and convenience of tobramycin inhalation powder (TIP™) versus tobramycin inhalation solution (TIS, TOBI®) for treating Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients aged ≥6 years.MethodsIn this open-label study, 553 patients were randomized 3:2 to TIP (total 112mg tobramycin) via the Novartis T-326 Inhaler or TIS 300mg/5mL via PARI LC® PLUS nebulizer twice daily for three treatment cycles (28 days on-drug, 28 days off-drug). Safety, efficacy, and treatment satisfaction outcomes were evaluated.ResultsTIP was generally well-tolerated; adverse events were similar in both groups. The rate of cough suspected to be study drug related was higher in TIP-treated patients (TIP: 25.3%; TIS: 4.3%), as was the overall discontinuation rate (TIP: 26.9%; TIS: 18.2%). Increases in FEV(1)% predicted from baseline to Day 28 of Cycle 3 were similar between groups; the mean reduction in sputum P. aeruginosa density (log(10) CFU/g) on Day 28 of Cycle 3 was also comparable between groups. Administration time was significantly less for TIP (mean: 5.6 versus 19.7min, p<0.0001). Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction.ConclusionsTIP has a safety and efficacy profile comparable with TIS, and offers a far more convenient treatment option for pseudomonas lung infection in CF.Copyright © 2010 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
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