Methods of treatment of endobronchial infections

Abstract

The present invention provides methods for the treatment of an endobronchial infection in a patient by administering to the endobronchial system of the patient a dry powder aerosol composition comprising from 90 to 130 mg of an aminoglycoside antibiotic one to three times a day for a first treatment period of 20 to 36 days.

Description

[0001]This application claims the benefit of U.S. Provisional Application No. 60 / 580,848, filed Jun. 18, 2004, which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to new and improved methods for treatment of susceptible endobronchial infections in patients with dry powder formulations of aminoglycoside antibiotics, such as tobramycin.BACKGROUND OF THE INVENTION[0003]Cystic fibrosis (CF) is the most common life-shortening genetic disease in the United States and Northern Europe, affecting approximately 30,000 individuals in the United States (Cunningham, J. C. et al., “An Introduction to Cystic Fibrosis for Patients and Families,” 5th ed., Bethesda: Cystic Fibrosis Foundation (2003)) and a similar number of individuals in Western Europe. The genetic defect in this autosomal recessive disease is a mutation in the CF transmembrane conductance regulator (CFTR) gene, which codes for a chloride-channel protein (Collins, F. S....

AI Technical Summary

Benefits of technology

This method enhances the delivery of aminoglycosides directly to the lung tissue, increasing patient compliance and therapeutic efficacy by reducing administration time and costs, while maintaining effective antibacterial levels, even in the presence of inhibitory sputum conditions.

Problems solved by technology

However, parenteral aminoglycosides, as highly polar agents, penetrate poorly into the endobronchial space.

Although this regimen was found to be both safe and efficacious, it is costly and inconvenient.

The Pulmozyme Study Group,”N Engl J Med 331(10):637-42 (1994)) are all prescribed chronically, creating a potential for significant treatment burden for persons with CF.

It has been shown that adherence to therapies is a significant problem for persons with CF (Conway, S. P. et al., “Compliance with treatment in adult patients with cystic fibrosis,”Thorax 51(1):29-33 (1996)) and that lack of compliance can vary by specific treatment (Abbott J et al., “Treatment Compliance in Adults with Cystic Fibrosis,”Thorax 49(2):115-20 (1994)).

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