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Inhaled tobramycin

J Stuart Elborn, Anne-Lise Vataire, Ayako Fukushima, Samuel Aballea, Amine Khemiri, Curtis Moore, Goran Medic, Michiel E H Hemels
PURPOSE: In Europe, 4 inhaled antibiotics (tobramycin, colistimethate sodium, aztreonam, and levofloxacin) are currently approved for the treatment of chronic Pseudomonas aeruginosa lung infection in patients with cystic fibrosis (CF). Levofloxacin inhalation solution (LIS) is the most recently approved inhaled antibiotic for adult patients with CF. A systematic literature review and Bayesian network meta-analysis (NMA) was conducted to compare the relative short-term (4 weeks) and long-term (24 weeks) outcomes of these inhaled antibiotics versus LIS...
September 28, 2016: Clinical Therapeutics
Thaigarajan Parumasivam, Sharon S Y Leung, Patricia Tang, Citterio Mauro, Warwick Britton, Hak-Kim Chan
The routine of loading multiple capsules for delivery of high-dose antibiotics is time consuming, which may reduce patient adherence to inhaled treatment. To overcome this limitation, an investigation was carried out using four modified versions of the Aerolizer® that accommodate a size 0 capsule for delivery of high payload formulations. In some prototypes, four piercing pins of 0.6 mm each were replaced with a single centrally located 1.2-mm pin and one-third reduced air inlet of the original design. The performance of these inhalers was evaluated using spray-dried antibiotic powders with distinct morphologies: spherical particles with a highly corrugated surface (colistin and tobramycin) and needle-like particles (rifapentine)...
September 27, 2016: AAPS Journal
Lindsay J Marshall, Wilson Oguejiofor, Robert Price, Jagdeep Shur
The airways of most people with cystic fibrosis are colonized with biofilms of the Gram-negative, opportunistic pathogen Pseudomonas aeruginosa. Delivery of antibiotics directly to the lung in the form of dry powder aerosols offers the potential to achieve high local concentrations directly to the biofilms. Unfortunately, current aerosolised antibiotic regimes are unable to efficiently eradicate these biofilms from the airways. We investigated the ability of the innate antimicrobial, lactoferrin, to enhance the activity of two aminoglycoside antibiotics (tobramycin and gentamicin) against biofilms of P...
September 11, 2016: International Journal of Pharmaceutics
John Massie, Phillip J Robinson, Peter J Cooper
There have been dramatic changes in the care of children with cystic fibrosis (CF) from 1965 to 2015. The initial improvements were the result of incremental gains in medical knowledge and better use of available therapies. Some CF-specific drugs were developed (recombinant human DNase and purified tobramycin for inhalation), but these simply delayed the progression of the lung damage. The discovery of the CF transmembrane conductance regulator gene in 1989 created an explosion of knowledge of airway biology and CF pathophysiology...
September 1, 2016: Journal of Paediatrics and Child Health
Joachim Riethmüller, Gloria Herrmann, Ute Graepler-Mainka, Dorothea Hellwig, Hans-Eberhard Heuer, Susanne Heyder, Holger Köster, Birte Kinder, Kristina Kröger, Klaus Paul, Krystyna Poplawska, Volker O Melichar, Christina Smaczny, Uwe Mellies
BACKGROUND/AIMS: In cystic fibrosis (CF), chronic microbial lung infections are difficult to treat and cause morbidity and increased mortality. METHODS: In a multicentre, open-label, exploratory, non-interventional study, inhaled tobramycin (300 mg twice daily) and colistin (1 million I.U. twice daily) were sequentially combined with the aim to investigate the effect on 41 CF patients with chronic P. aeruginosa infections for six months (mean age 24 ± 10.8y). RESULTS: Six patients had adverse events that were assessed as being related to treatment...
2016: Cellular Physiology and Biochemistry
Wallace B Wee, Scott Tavernini, Andrew R Martin, Israel Amirav, Carina Majaesic, Warren H Finlay
BACKGROUND: Pediatric tracheostomies are not uncommon and aerosols allow for targeted lung therapy. However, there is little literature that quantifies aerosol delivery through tracheostomies. Nebulizers are commonly used in delivering tobramycin, but there are drawbacks, for example, time burden. Dry powder inhalers (DPIs) can deliver higher payloads in less time. However, no data exist assessing DPIs with tracheostomies. OBJECTIVE: The study's aim was to quantify the amount of aerosolized tobramycin delivered to the lungs of in vitro tracheostomized spontaneously breathing pediatric models with the TOBI(®) Podhaler™ (Podhaler) and the PARI LC Plus(®) (LC Plus)...
August 26, 2016: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Stephen B Vickery, David McClain, Kurt A Wargo
Ceftolozane-tazobactam, a novel β-lactam/β-lactamase inhibitor, was recently approved for the treatment of complicated urinary tract and intraabdominal infections, as monotherapy and in combination with metronidazole, respectively. Ceftolozane-tazobactam exhibits a wide spectrum of activity against both gram-positive bacteria, gram-negative bacteria including multidrug-resistant (MDR) Pseudomonas aeruginosa, and some anaerobic bacteria. Although not currently approved for any pulmonary indication, studies have demonstrated excellent distribution to epithelial lining fluid, indicating that it may be an alternative agent to use in the treatment of respiratory tract infections caused by MDRP...
October 2016: Pharmacotherapy
Katrine Fjaellegaard, Melda Dönmez Sin, Andrea Browatzki, Charlotte Suppli Ulrik
To provide an update on efficacy and safety of antibiotic treatments for stable non-cystic fibrosis (CF) bronchiectasis (BE). Systematic review based on the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines was done. Twenty-six studies (1.898 patients) fulfilled the inclusion criteria. Studies of inhaled tobramycin have revealed conflicting results regarding quality of life (QoL), exacerbations and admissions, but may result in sputum cultures negative for Pseudomonas aeruginosa, whereas studies investigating the effect of inhaled gentamycin have shown positive effects on sputum bacterial density, decrease in sputum cultures positive for P...
August 9, 2016: Chronic Respiratory Disease
Laura C McCaughey, Neil D Ritchie, Gillian R Douce, Thomas J Evans, Daniel Walker
Protein antibiotics, known as bacteriocins, are widely produced by bacteria for intraspecies competition. The potency and targeted action of bacteriocins suggests that they could be developed into clinically useful antibiotics against highly drug resistant Gram-negative pathogens for which there are few therapeutic options. Here we show that Pseudomonas aeruginosa specific bacteriocins, known as pyocins, show strong efficacy in a murine model of P. aeruginosa lung infection, with the concentration of pyocin S5 required to afford protection from a lethal infection at least 100-fold lower than the most commonly used inhaled antibiotic tobramycin...
2016: Scientific Reports
Urte Sommerwerck, Isabel Virella-Lowell, Gerhild Angyalosi, Andrea Viegas, Weihua Cao, Laurie Debonnett
OBJECTIVE: Long-term treatment with inhaled antibiotics is recommended for chronic Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) patients. The ETOILES study ( identifier: NCT01519661) evaluated the safety of tobramycin inhalation powder (TIP) for 1 year. RESEARCH DESIGN AND METHODS: This single-arm, open-label, multicenter, phase IV trial, enrolled CF patients aged ≥6 years, with baseline FEV1 ≥25%-≤75% predicted and Pa infection, and assessed the safety of TIP over six cycles in terms of the incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs)...
November 2016: Current Medical Research and Opinion
Daniel L Hamilos
Chronic rhinosinusitis (CRS) is highly prevalent in patients with cystic fibrosis (CF) and accounts for significant morbidity and contribution to CF lung disease. Mutations of the cystic fibrosis transmembrane regulator gene occur with increased prevalence in patients with CRS without CF, suggesting some contribution to CRS pathophysiology. Nasal polyps (NPs) occur with increased prevalence in patients with CF of all ages and have a more neutrophilic appearance with fewer eosinophils and increased submucosal glandular elements in comparison to NPs from patients without CF...
July 2016: Journal of Allergy and Clinical Immunology in Practice
Christina A Sutherland, Jamie E Verastegui, David P Nicolau
BACKGROUND: The purpose of this study was to define the potency of amikacin and comparator agents against a collection of blood and respiratory nosocomial isolates implicated in ICU based pulmonary infections gathered from US hospitals. METHODS: Minimum inhibitory concentrations of amikacin, aztreonam, cefepime, ceftazidime, ceftolozane/tazobactam, ceftriaxone, ciprofloxacin, imipenem, meropenem, piperacillin/tazobactam and tobramycin were tested against 2460 Gram-negative isolates...
2016: Annals of Clinical Microbiology and Antimicrobials
N Emiralioglu, E Yalcin, A Meral, B Sener, D Dogru, U Ozcelik, N Kiper
WHAT IS KNOWN AND OBJECTIVE: Antibiotic therapy aimed at eradicating Pseudomonas aeruginosa (Pa), and improved regimens to treat chronic Pa infection have played a major role in increasing the median survival of patients with cystic fibrosis (CF). However, different clinical centres use varying eradication regimens. The aim of this study was to evaluate the efficacy of multiple eradication treatments against initial Pa infection and to determine the factors affecting the treatment success...
August 2016: Journal of Clinical Pharmacy and Therapeutics
Patrick A Flume, John P Clancy, George Z Retsch-Bogart, D Elizabeth Tullis, Mark Bresnik, P Alex Derchak, Sandra A Lewis, Bonnie W Ramsey
BACKGROUND: Inhaled antibiotics are standard of care for treating chronic pseudomonal respiratory infections in cystic fibrosis patients, initially approved for intermittent administration. However, use of continuous inhaled antibiotic regimens of differing combinations is growing. METHODS: This double-blind trial compared continuous alternating therapy (CAT) to an intermittent treatment regimen. Subjects were treated with 3cycles of 28-days inhaled aztreonam (AZLI) or placebo 3-times daily alternating with 28-days open-label tobramycin inhalation solution (TIS)...
May 24, 2016: Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society
Małgorzata Olszowiec-Chlebna, Agnieszka Koniarek-Maniecka, Włodzimierz Stelmach, Katarzyna Smejda, Joanna Jerzyńska, Paweł Majak, Monika Białas, Iwona Stelmach
INTRODUCTION: Severity of lung disease varies in patients with the same CFTR genotype. It suggests that other factors affect the severity of cystic fibrosis (CF). The aim of the study was to identify risk factors that determine lung function decline in Polish cystic fibrosis children. MATERIAL AND METHODS: The follow-up time was no less than 5 years of respiratory status observation based on the forced expiratory volume in 1 s value (FEV1). The socio-economic data, perinatal interview, presence of meconium ileus (MI), time of CF diagnosis, initiation of tobramycin inhalation solution (TIS), pancreatic function, sensitization to Aspergillus fumigatus, presence of impaired glucose tolerance (IGT) or diabetes mellitus, chronic bacterial colonization and number of exacerbations and hospitalizations were assessed...
April 1, 2016: Archives of Medical Science: AMS
Alfred Haynes, David Geller, Jeffry Weers, Brian Ament, Richard Pavkov, Richard Malcolmson, Laurie Debonnett, Paul Mastoridis, Anthony Yadao, Silvia Heuerding
INTRODUCTION: TOBI(®) Podhaler™ is a capsule-based drug-device combination (tobramycin inhalation powder [TIP] 28 mg capsules via unit-dose dry powder T-326 Inhaler [Podhaler™]) developed for treatment of Pseudomonas aeruginosa infection in cystic fibrosis (CF). We explored how inspiratory flow profiles and mouth-throat geometries affect drug delivery with the T-326 Inhaler. METHODS: Inspiratory flow profiles were recorded from 38 subjects aged 6-71 who had CF and varying degrees of lung function impairment...
May 1, 2016: Pediatric Pulmonology
Bing Zhu, Matteo Padroni, Gaia Colombo, Gary Phillips, John Crapper, Paul M Young, Daniela Traini
The aerosol performance and delivery characteristics of tobramycin for the treatment of respiratory infection were evaluated using the Orbital™, a multi-breath, high dose, dry powder inhaler (DPI). Micronised tobramycin was prepared and tested in the Orbital and in the commercially available TOBI Podhaler (Novartis AG). Furthermore, the TOBI Podhaler formulation containing tobramycin as Pulmospheres was tested in both the commercial Podhaler device (T-326) and Orbital for comparison. By varying the puck geometry of the Orbital, it was possible to deliver equivalent doses of micronised tobramycin (114...
April 5, 2016: International Journal of Pharmaceutics
H Kitt, W Lenney, F J Gilchrist
BACKGROUND: Chronic infection with Burkholderia cepacia complex (BCC) has a detrimental effect on morbidity and mortality for patients with cystic fibrosis (CF). It is therefore logical to attempt to eradicate new isolates however there is a paucity of information to guide treatment. We report the successful eradication of new isolates of BCC in two children with CF. CASE PRESENTATION: Burkholderia cepacia was successfully eradicated in a 14 year old boy with CF and Burkholderia gladioli was successfully eradicated in a six year old girl with CF...
2016: BMC Pharmacology & Toxicology
Ivana d'Angelo, Brunella Perfetto, Gabriella Costabile, Veronica Ambrosini, Pina Caputo, Agnese Miro, Roberta d'Emmanuele di Villa Bianca, Raffaella Sorrentino, Giovanna Donnarumma, Fabiana Quaglia, Francesca Ungaro
We have recently demonstrated that the specific inhibition of nuclear factor-κB by a decoy oligonucleotide (dec-ODN) delivered through inhalable large porous particles (LPP) made of poly(lactic-co-glycolic acid) (PLGA) may be highly beneficial for long-term treatment of lung inflammation. Nevertheless, besides chronic inflammation, multifunctional systems aimed to control also infection are required in chronic lung diseases, such as cystic fibrosis (CF). In this work, we tested the hypothesis that engineering PLGA-based LPP with branched poly(ethylenimine) (PEI) may improve LPP properties for pulmonary delivery of dec-ODN, with particular regard to the treatment of Pseudomonas aeruginosa lung infections...
May 9, 2016: Biomacromolecules
Marcel Hoppentocht, Onno W Akkerman, Paul Hagedoorn, Jan-Willem C Alffenaar, Tjip S van der Werf, Huib A M Kerstjens, Henderik W Frijlink, Anne H de Boer
RATIONALE: Bronchiectasis is a condition characterised by dilated and thick-walled bronchi. The presence of Pseudomonas aeruginosa in bronchiectasis is associated with a higher hospitalisation frequency and a reduced quality of life, requiring frequent and adequate treatment with antibiotics. OBJECTIVES: To assess local tolerability and the pharmacokinetic parameters of inhaled excipient free dry powder tobramycin as free base administered with the Cyclops dry powder inhaler to participants with non-cystic fibrosis bronchiectasis...
2016: PloS One
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