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The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial

Open access
Konstan, Michael W., Flume, Patrick A., Kappler, Matthias, Chiron, Raphaël, Higgins, Mark, Brockhaus, Florian, Zhang, Jie, Angyalosi, Gerhild, He, Ellie, Geller, David E.·2011·Journal of Cystic Fibrosis
DOI 10.1016/j.jcf.2010.10.003
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Abstract

Background A 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. Methods In this open-label study, 553 patients were randomized 3:2 to TIP (total 112 mg tobramycin) via the Novartis T-326 Inhaler or TIS 300 mg/5 mL 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. Results TIP 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 FEV1 % predicted from baseline to Day 28 of Cycle 3 were similar between groups; mean reduction in sputum Pseudomonas aeruginosa density (log10 CFU/g) on Day 28 of Cycle 3 was also comparable between groups. Administration time was significantly less for TIP (mean: 5.6 versus 19.7 minutes, p<0.0001). Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction. Conclusions TIP has a safety and efficacy profile comparable with TIS, and offers a far more convenient treatment option for pseudomonas lung infection in CF.

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Metadata

Authors
Konstan, M. W., Flume, P. A., Kappler, M., Chiron, R., Higgins, M., Brockhaus, F., Zhang, J., Angyalosi, G., He, E., & Geller, D. E.
Venue
Journal of Cystic Fibrosis
Publisher
Elsevier BV
Published
2011-01
Volume
10
Issue
1
Pages
54-61
ISSN
1569-1993 (ISSN-L)
DOI
10.1016/j.jcf.2010.10.003
OpenAlex
W2075069205
Cited by
314
References
21
FWCI
14.76
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. https://app.cochat.ai/papers/10.1016/j.jcf.2010.10.003
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Konstan, M. W., Flume, P. A., Kappler, M., Chiron, R., Higgins, M., Brockhaus, F., Zhang, J., Angyalosi, G., He, E., & Geller, D. E. (2011). Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. Journal of Cystic Fibrosis. https://doi.org/10.1016/j.jcf.2010.10.003

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.