Konstan, M. W. et al. Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. J. Cyst. Fibros. 10, 54-61

Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Journal of cystic fibrosis: official journal of the European Cystic Fibrosis Society (Impact Factor: 3.48). 11/2010; 10(1):54-61. DOI: 10.1016/j.jcf.2010.10.003
Source: PubMed


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 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.
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.
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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Available from: David E Geller, Oct 18, 2014
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    • "Furthermore, inhaled antibiotics have been used off-label for the treatment of ventilator-associated pneumonia (VAP) [2] [14], chronic infections in patients with non-CF-related bronchiectasis [15] [16] and mycobacterial pulmonary infections [17] [18], whilst inhaled antifungal agents have been used in patients with invasive pulmonary aspergillosis [19] [20] and Pneumocystis jirovecii pneumonia [21]. With regard to inhaled antibacterial drugs, there is considerable literature regarding aminoglycosides [22] [23] [24], polymyxins [25] [26] and aztreonam [27] [28], but there are fewer references to other classes of antibiotics. In this systematic review, we sought to evaluate the published studies that present clinical outcomes related to the use of inhaled antibacterial agents other than aminoglycosides, polymyxins or aztreonam. "
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    ABSTRACT: We sought to evaluate published evidence regarding clinical or microbiological outcomes related to the use of inhaled antibiotics other than aminoglycosides, polymyxins and aztreonam. A systematic search of PubMed and Scopus databases as well as bibliographies of eligible articles was performed. In total, 34 eligible studies were identified. Among several inhaled β-lactams, ceftazidime was used with varying success in the prevention and treatment of ventilator-associated pneumonia (VAP) and improved clinical outcomes in chronic Pseudomonas aeruginosa lower respiratory tract infections (LRTIs) in patients with cystic fibrosis (CF) or bronchiectasis. Inhaled vancomycin, as an adjunctive therapy, was effective in treating Gram-positive VAP, whilst inhaled levofloxacin, ciprofloxacin and an inhaled combination of fosfomycin and tobramycin were associated with improved microbiological or clinical outcomes in chronic LRTI in patients with CF or bronchiectasis. In conclusion, published evidence is heterogeneous with regard to antibiotics used, studied indications, patient populations and study designs. Therefore, although the currently available data are encouraging, no safe conclusion regarding the effectiveness and safety of the drugs in question can be reached.
    International Journal of Antimicrobial Agents 11/2014; 45(3). DOI:10.1016/j.ijantimicag.2014.10.008 · 4.30 Impact Factor
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    • "In the EAGER (Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients) trial,50 inhalation dry powder was evaluated versus inhalation solution. The increase in FEV1 was equal for the two groups at all times of spirometric evaluation. "
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    ABSTRACT: Currently almost all antibiotics are administered by the intravenous route. Since several systems and situations require more efficient methods of administration, investigation and experimentation in drug design has produced local treatment modalities. Administration of antibiotics in aerosol form is one of the treatment methods of increasing interest. As the field of drug nanotechnology grows, new molecules have been produced and combined with aerosol production systems. In the current review, we discuss the efficiency of aerosol antibiotic studies along with aerosol production systems. The different parts of the aerosol antibiotic methodology are presented. Additionally, information regarding the drug molecules used is presented and future applications of this method are discussed.
    Drug Design, Development and Therapy 10/2013; 7:1115-1134. DOI:10.2147/DDDT.S51303 · 3.03 Impact Factor
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    • "Another approach would be to change the formulation of current medications to reduce the treatment burden, and hopefully increase adherence to the medication. An example is the development of a dry powder to replace an aerosol medication, such as tobramycin inhalation powder, which has been shown to be equivalent to tobramycin inhalation solution in terms of efficacy, but is associated with a markedly reduced treatment time and greater patient satisfaction [150]. There is also a need for the development of additional agents within the current classes to enhance the treatment options should current treatments seem to be less effective. "
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    ABSTRACT: Since the discovery of the gene associated with cystic fibrosis (CF), there has been tremendous progress in the care of patients with this disease. New therapies have entered the market and are part of the standard treatment of patients with CF, and have been associated with marked improvement in survival. Now there are even more promising therapies directed at different components of the pathophysiology of this disease. In this review, our current knowledge of the pathophysiology of lung disease in patients with CF is described, along with the current treatment of CF lung disease, and the therapies in development that offer great promise to our patients.
    BMC Medicine 08/2012; 10(1):88. DOI:10.1186/1741-7015-10-88 · 7.25 Impact Factor
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