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Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.
J Cyst Fibros. 2011 Jan; 10(1):54-61.JC

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 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.

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 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.

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.

Authors+Show Affiliations

Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH, USA. michael.konstan@UHhospitals.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

21075062

Citation

Konstan, Michael W., et al. "Safety, Efficacy and Convenience of Tobramycin Inhalation Powder in Cystic Fibrosis Patients: the EAGER Trial." Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society, vol. 10, no. 1, 2011, pp. 54-61.
Konstan MW, Flume PA, Kappler M, et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. J Cyst Fibros. 2011;10(1):54-61.
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 : Official Journal of the European Cystic Fibrosis Society, 10(1), 54-61. https://doi.org/10.1016/j.jcf.2010.10.003
Konstan MW, et al. Safety, Efficacy and Convenience of Tobramycin Inhalation Powder in Cystic Fibrosis Patients: the EAGER Trial. J Cyst Fibros. 2011;10(1):54-61. PubMed PMID: 21075062.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. AU - Konstan,Michael W, AU - Flume,Patrick A, AU - Kappler,Matthias, AU - Chiron,Raphaël, AU - Higgins,Mark, AU - Brockhaus,Florian, AU - Zhang,Jie, AU - Angyalosi,Gerhild, AU - He,Ellie, AU - Geller,David E, Y1 - 2010/11/12/ PY - 2010/08/05/received PY - 2010/10/12/revised PY - 2010/10/14/accepted PY - 2010/11/16/entrez PY - 2010/11/16/pubmed PY - 2011/5/4/medline SP - 54 EP - 61 JF - Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society JO - J Cyst Fibros VL - 10 IS - 1 N2 - 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 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. 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 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. 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. SN - 1873-5010 UR - https://www.unboundmedicine.com/medline/citation/21075062/Safety_efficacy_and_convenience_of_tobramycin_inhalation_powder_in_cystic_fibrosis_patients:_The_EAGER_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1569-1993(10)00144-X DB - PRIME DP - Unbound Medicine ER -