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)

Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa Infection [Not yet recruiting]
The use of inhaled medications for the treatment of pulmonary diseases allows for the delivery of a high concentration of a drug at the site of disease with reduced systemic absorption and risk of systemic adverse effects. Inhaled Tobramycin has been successfully used in the maintenance treatment of CF patients with chronic colonization with PA (Pseudomonas aeruginosa). In the CF population TOBI has been proven to improve lung functions, decrease the density of the PA in the sputum, decrease hospitalizations, and reduce the risk of mortality. Non CF Bronchiectasis share many features in common with CF, including frequent colonization with PA that leads to deterioration in lung function and increased morbidity. A recent Cochrane review concluded that there is a small benefit for the use of prolonged antibiotics in the treatment of bronchiectasis, however further randomized controlled trials with adequate power and standardized end points are required. There have been reports in the literature describing the efficacy of inhaled tobramycin the treatment of patients with non CF bronchiectasis with eradication of PA, and significant improvement in respiratory symptoms. There were however patients who discontinued treatment due to adverse events most commonly cough wheezing and dyspnea. (Scheinberg and Shore, Chest 2005). TOBI Podhaler is a dry powder inhaler that was recently launched, and is much easier and faster to use compared to nebulised Tobramycin. To the best of our knowledge Tobramycin dry powder formulation has not yet been trialed in patients with non CF bronchiectasis. The purpose of this trial is to assess the efficacy and tolerability of TOBI Podhaler in patients with non CF bronchiectasis, and to gather more data on the benefit of continuous antibiotic therapy in patients with non CF bronchectais.

Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects [Completed]
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects. Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.

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

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years [Active, not recruiting]
This study will investigate the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer [Active, not 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.

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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 >>