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Tobi (Tobramycin Inhalation) - Summary

 
 



TOBI SUMMARY

TOBI«áis 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.áaeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6áyears, patients with FEV1á<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 (FEVÔéü) percent of predicted normal, and to compare their safety in patients with cystic fibrosis and chronic infection of the lungs with P. aeruginosa.

Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis [Recruiting]
Cystic fibrosis is the most common inherited life limiting condition which affects children. Patients with it develop lung infections which become difficult to clear, and damage the lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed "intravenous antibiotics"). This has without doubt improved survival. However, all treatments have side effects. Tobramycin can cause kidney damage. The investigators have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening.

The investigators plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. The investigators will randomly allocate them to receive it at either 0800h or 2200h. The investigators will measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring the amount of tobramycin in the blood stream after administering the antibiotic. For each patient the study will last for the duration of the course of antibiotics. This is decided by the doctor looking after the patient (rather than the researcher), and would typically be 14 days. The investigators will also measure substances in the blood and urine ("biomarkers") which are sensitive indicators of low levels of kidney injury. The investigators will monitor lung function and lung bacteria in both the groups to ensure that the patients in both groups improve by the same amount.

If the preliminary data are proved correct, this research will allow investigators to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years [Recruiting]
This study will investigate the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Pharmacokinetic Bioequivalence Study of Nebcinal´┐Ż 150mg/3ml Administered by Aeroneb´┐Ż Idehaler´┐Ż Versus Tobi´┐Ż 300mg/5ml Administered by Pari LC Plus´┐Ż /Pulmoaid´┐Ż in Patients With Cystic Fibrosis [Recruiting]
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®

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).

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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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