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Inhaled antibiotics for the treatment of chronic bronchopulmonary Pseudomonas aeruginosa infection in cystic fibrosis: Systematic review of randomised controlled trials

Ramón y Cajal University Hospital, Unit of Bronchiestasis and Cystic Fibrosis, Respiratory Department , Madrid , Spain .
Expert Opinion on Pharmacotherapy (Impact Factor: 3.09). 04/2013; 14(9). DOI: 10.1517/14656566.2013.790366
Source: PubMed

ABSTRACT Introduction: Inhaled antibiotics are probably the safest and most effective therapy for Pseudomonas aeruginosa chronic lung infection in cystic fibrosis (CF) patients. Areas covered: To summarise the available evidence, a systematic review of the three currently available inhaled antibiotics (aztreonam lysine (AZLI), colistin (COL) and tobramycin (TOB)) was performed. The three AZLI placebo-controlled studies showed that the improvements in FEV1 and mean sputum P. aeruginosa density were statistically significant better than with placebo. The two COL placebo-controlled studies involved few patients but showed that COL was better than placebo in terms of maintenance of some pulmonary function parameters. The tobramycin inhalation solution (TIS) and tobramycin inhalation powder studies showed that the efficacy of both formulations was similar but significantly better than placebo. In the comparative studies, TIS showed more efficacy than COL solution, colistin inhalation powder showed non-inferiority to TIS and AZLI was superior to TIS. Expert opinion: Placebo-controlled and comparative clinical trials have shown that clinical evidence of inhaled antibiotics is very different. The choice of treatment for each individual CF patient must be based on the features of the drug (clinical evidence on efficacy and safety), the inhalation system and the patient characteristics. Development of new inhaled antibiotics will allow new end points of efficacy and therapy regimens to be assessed.

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    • "One of the reasons is that individuals with Burkholderia cepacia complex infection have historically been excluded from efficacy trials of inhaled antibiotics [5] [8] [9]. Aztreonam lysine (Cayston, Gilead Sciences Inc.) is a new antibiotic for inhalation, indicated for the treatment of chronic bronchial infection by P. aeruginosa in CF patients [12] [14]. "
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    ABSTRACT: There are not many articles about the chronic bronchial infection/colonization in patients with underlying lung disease other than cystic fibrosis (CF), especially with non-CF bronchiectasis (NCFBQ). The prevalence of B. cepacia complex is not well known in NCFBQ. The vast majority of published clinical data on Burkholderia infection in individuals with CF is comprised of uncontrolled, anecdotal, and/or single center experiences, and no consensus has emerged regarding treatment. We present two cases diagnosed with bronchiectasis (BQ) of different etiology, with early pulmonary infection by B. cepacia complex, which was eradicated with inhaled aztreonam lysine.
    09/2014; 2014:192146. DOI:10.1155/2014/192146
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    VII Curso avanzado en Infecciones Respiratorias 2013, Edited by Rosario Menéndez, Rafael Zalacaín, 01/2013: chapter Estado actual de los antibióticos inhalados: pages 19-32; Springer SBM Spain, S.A.U.., ISBN: 978-84-695-8192-6
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    ABSTRACT: The development of inhaled antibiotics to treat lung infection is an active field, with four approved products in the USA and more in the late stages of clinical development. The efficacies of TOBI® tobramycin (Novartis) and Cayston® aztreonam lysate (Gilead), the approved inhaled antibiotics for cystic fibrosis (CF) patients colonized with Pseudomonas aeruginosa, have been well documented. Recent approvals for a second-generation tobramycin solution, Bethkis®, and a tobramycin powder formulation in a dry-powder inhaler (DPI), TOBI Podhaler®, indicate that the inhaled antibiotic marketplace in CF is becoming very competitive. Other indications are also receiving interest. While there have been a number of recent reviews from a clinical, technical or regulatory perspective in the field of inhaled antibiotics, as well as others focused on a specific product or data from a recent clinical trial, there have not been any that describe the patent coverage of these products. This review addresses that missing piece.
    09/2013; 2(5):647-63. DOI:10.4155/ppa.13.47
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