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

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 inh...

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Vydáno v:Journal of cystic fibrosis Ročník 10; číslo 1; s. 54 - 61
Hlavní autoři: Konstan, Michael W., Flume, Patrick A., Kappler, Matthias, Chiron, Raphaël, Higgins, Mark, Brockhaus, Florian, Zhang, Jie, Angyalosi, Gerhild, He, Ellie, Geller, David E.
Médium: Journal Article
Jazyk:angličtina
Vydáno: Netherlands Elsevier B.V 01.01.2011
Témata:
Administration, Inhalation
Adolescent
Adult
Aged
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - adverse effects
Child
Cough - chemically induced
Cystic fibrosis
Cystic Fibrosis - complications
Cystic Fibrosis - physiopathology
Drug Administration Schedule
Drug Delivery Systems
Drug Monitoring
Dry Powder Inhalers
Female
Humans
Lung infection
Male
Middle Aged
Powders
Pseudomonas aeruginosa
Pseudomonas aeruginosa - drug effects
Pseudomonas aeruginosa - isolation & purification
Pseudomonas Infections - drug therapy
Pseudomonas Infections - etiology
Pseudomonas Infections - physiopathology
Pulmonary/Respiratory
Respiratory Function Tests
Sputum - drug effects
Sputum - microbiology
Tobramycin - administration & dosage
Tobramycin - adverse effects
Tobramycin inhalation powder (TIP™)
Treatment Outcome
Tobramycin inhalation powder (TIP™)
Cystic fibrosis
Pseudomonas aeruginosa
Lung infection
ISSN:1569-1993, 1873-5010, 1873-5010
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Shrnutí: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. 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. 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 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 19.7 min, p < 0.0001). Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction. TIP has a safety and efficacy profile comparable with TIS, and offers a far more convenient treatment option for pseudomonas lung infection in CF.
Bibliografie:ObjectType-Article-1
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ISSN:1569-1993
1873-5010
1873-5010
DOI:10.1016/j.jcf.2010.10.003