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Tobi (Tobramycin Inhalation) - Summary

 
 



TOBI SUMMARY

TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer.

TOBI® is indicated for the management of cystic fibrosis patients with P. aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia (see CLINICAL STUDIES).


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NEWS HIGHLIGHTS

Published Studies Related to Tobi (Tobramycin Inhalation)

Higher tobramycin concentration and vibrating mesh technology can shorten antibiotic treatment time in cystic fibrosis. [2011.04]
Poor adherence to recommended therapy in cystic fibrosis (CF) is often because of the time demands of therapy... These results demonstrate the possibility of delivering equivalent levels of tobramycin much faster into the lungs of CF patients when using eFlow(R), a very efficient electronic nebulizer.

Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial. [2011.01]
BACKGROUND: A light-porous-particle, dry-powder formulation of tobramycin was developed, using PulmoSphere(R) 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(R)) for treating Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients aged >/=6 years... 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. Copyright A(c) 2010 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Lung deposition of inhaled tobramycin with eFlow rapid/LC Plus jet nebuliser in healthy and cystic fibrosis subjects. [2011.01]
BACKGROUND: Reducing nebulisation times for tobramycin solution for inhalation in cystic fibrosis (CF) may improve compliance... CONCLUSIONS: eFlow rapid reduces the nebulisation time of tobramycin and can potentially improved compliance in patients with CF. Copyright A(c) 2010 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

The use of high resolution computerized tomography (HRCT) of the chest in evaluating the effect of tobramycin solution for inhalation in cystic fibrosis lung disease. [2010.05]
OBJECTIVES: To compare the usefulness of HRCT of the chest versus spirometric measures (PFTs) in evaluating the effect of tobramycin solution for inhalation (TSI) in cystic fibrosis (CF)... CONCLUSION: HRCT seems to be more sensitive in detecting treatment effect than PFT in CF patients with mild lung disease, especially following the first treatment period (visit 2). Total HRCT score showed some improvement at the end of the study, though not statistically significant. This is probably due to obtaining the HRCT an average of 30 days after completion of the TSI treatment, and selection of study population with mostly mild lung disease. This could indicate that the most significant improvement in the total HRCT score in this patient population occurs after the first treatment period with TSI.

Aerosolization of tobramycin (TOBI) with the PARI LC PLUS reusable nebulizer: which compressor to use? Comparison of the CR60 to the PortaNeb compressor. [2008.09]
Aerosol output, aerosol output rate, and aerosol size distribution are influenced by the compressed air flow rate through the nebulizer cup. Testing a nebulizer-compressor with a drug for inhalation in cystic fibrosis (CF) patients is mandatory prior to starting therapy...

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Clinical Trials Related to Tobi (Tobramycin Inhalation)

A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® [Recruiting]
The purpose of this study is to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in primary efficacy variable, forced expiratory volume in one second (FEV₁) percent of predicted normal, and to compare their safety in patients with cystic fibrosis and chronic infection of the lungs with P. aeruginosa.

A Single Arm 48-Week Follow-on Long Term Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® [Recruiting]
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer [Recruiting]
The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.

A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo [Recruiting]
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients [Recruiting]
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

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Reports of Suspected Tobi (Tobramycin Inhalation) Side Effects

Death (157)Infective Pulmonary Exacerbation of Cystic Fibrosis (87)Upper Respiratory Tract Infection (72)Dyspnoea (66)Cough (58)Pneumonia (54)Pseudomonas Infection (42)Lung Infection (37)Cystic Fibrosis (36)Pulmonary Function Test Decreased (30)more >>


Page last updated: 2011-12-09

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