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Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

2014-08-27 03:52:43 | BioPortfolio

Summary

Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

Tobramycin Inhalation Powder

Location

For information on a site near you, call 1-800-244-7668 Option "2"
Mobile
Alabama
United States

Status

Terminated

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:52:43-0400

Clinical Trials [1451 Associated Clinical Trials listed on BioPortfolio]

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo

This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

The purpose of this study is to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aerugin...

Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this tr...

Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

To assess whether the inhalative combination of Tobramycin/Colistin is more effective in reducing Pseudomonas colony forming units (CFUs) and improvement of lung function than Colistin in ...

PubMed Articles [2675 Associated PubMed Articles listed on BioPortfolio]

Dose administration manoeuvres and patient care in tobramycin dry powder inhalation therapy.

The purpose of this work was to study a new dry powder inhaler (DPI) of tobramycin capable to simplify the dose administration maneuvers to maximize the cystic fibrosis patient care in antibiotic inha...

Intermittent inhaled tobramycin and systemic cytokines response in CF patients with Pseudomonas aeruginosa.

CF pulmonary guidelines recommend alternate therapy (one month on, one month off) with inhaled tobramycin for chronic Pseudomonas aeruginosa colonization in cystic fibrosis (CF). Tobramycin-inhaled po...

Azithromycin for Early Pseudomonas Infection in Cystic Fibrosis: The Optimize Randomized Trial.

New isolation of Pseudomonas aeruginosa (Pa) is generally treated with inhaled antipseudomonal antibiotics such as tobramycin inhalation solution (TIS). A therapeutic approach complementing traditiona...

No easy road to better cystic fibrosis care in Eastern Europe?

Combined Pancreatic Islet-Lung-Liver Transplantation in a Pediatric Patient with Cystic Fibrosis-Related Diabetes.

Cystic fibrosis-related diabetes (CFRD) is the most frequent extrapulmonary complication of cystic fibrosis (CF).

Medical and Biotech [MESH] Definitions

An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

A chloride channel that regulates secretion in many exocrine tissues. Abnormalities in the CFTR gene have been shown to cause cystic fibrosis. (Hum Genet 1994;93(4):364-8)

A strain of mice widely studied as a model for cystic fibrosis. These mice are generated from embryonic stem cells in which the CFTR (cystic fibrosis transmembrane conductance regulator) gene is inactivated by gene targeting. As a result, all mice have one copy of this altered gene in all their tissues. Mice homozygous for the disrupted gene exhibit many features common to young cystic fibrosis patients, including failure to thrive, meconium ileus, and alteration of mucous and serous glands.

A device that delivers medication to the lungs in the form of a dry powder.

A species of STENOTROPHOMONAS, formerly called Xanthomonas maltophilia, which reduces nitrate. It is a cause of hospital-acquired ocular and lung infections, especially in those patients with cystic fibrosis and those who are immunosuppressed.

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