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Second Open Label Extension to Bridging Study CTBM100C2303

2014-07-23 21:10:27 | BioPortfolio

Summary

This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Infections

Intervention

Tobramycin inhalation powder

Location

Novartis Investigative Site
Pleven
Bulgaria

Status

Enrolling by invitation

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:27-0400

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Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

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...

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Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

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PubMed Articles [6559 Associated PubMed Articles listed on BioPortfolio]

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

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Preparation and Quality Evaluation of Salvianolic Acids and Tanshinones Dry Powder Inhalation.

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Characterisation of 40 mg/ml and 100 mg/ml tobramycin formulations for aerosol therapy with adult mechanical ventilation.

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Dry powder inhalers (DPI) are effective but forceful inhalation required to fluidize the powder may be difficult for children and patients with airway disease. Inspiromatic is a new generation active ...

Medical and Biotech [MESH] Definitions

Infections of the respiratory tract with fungi of the genus ASPERGILLUS. Infections may result in allergic reaction (ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS), colonization in pulmonary cavities as fungus balls (MYCETOMA), or lead to invasion of the lung parenchyma (INVASIVE PULMONARY ASPERGILLOSIS).

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

Lung infections with the invasive forms of ASPERGILLUS, usually after surgery, transplantation, prolonged NEUTROPENIA or treatment with high-doses of CORTICOSTEROIDS. Invasive pulmonary aspergillosis can progress to CHRONIC NECROTIZING PULMONARY ASPERGILLOSIS or hematogenous spread to other organs.

A mitosporic fungal genus occasionally causing human diseases such as pulmonary infections, mycotic keratitis, endocarditis, and opportunistic infections. Its teleomorph is BYSSOCHLAMYS.

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

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