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.

1 . A method for the treatment of an endobronchial infection in a patient, comprising 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. 
     
     
         2 . A method of  claim 1  wherein the first treatment period is followed by a second non-treatment period wherein no aminoglycoside antibiotic is administered to the endobronchial system of the patient. 
     
     
         3 . A method of  claim 1  wherein the aminoglycoside antibiotic is selected from the group consisting of gentamicin, amikacin, kanamycin, streptomycin, neomycin, netilmicin and tobramycin, or a pharmaceutically acceptable salt thereof. 
     
     
         4 . A method of  claim 3  wherein the aminoglycoside antibiotic is tobramycin, or a pharmaceutically acceptable salt thereof. 
     
     
         5 . A method of  claim 4  wherein the aerosol powder composition comprises from 100 to 120 mg of tobramycin. 
     
     
         6 . A method of  claim 5  wherein the aerosol powder composition comprises from 110 to 115 mg of tobramycin. 
     
     
         7 . A method of  claim 1  wherein the aerosol powder composition administered to the patient is divided into two to six unit doses. 
     
     
         8 . A method of  claim 7  wherein the aerosol powder composition administered to the patient is divided into three to five unit doses. 
     
     
         9 . A method of  claim 8  wherein the aerosol powder composition is divided into four unit doses. 
     
     
         10 . A method of  claim 2  wherein the second non-treatment period is from 20 to 36 days. 
     
     
         11 . A method of  claim 2  wherein the first treatment period is from 26 to 30 days. 
     
     
         12 . A method of  claim 11  wherein the second non-treatment period is from 26 to 30 days. 
     
     
         13 . A method of  claim 2  wherein the first treatment period is for 28 days. 
     
     
         14 . A method of  claim 13  wherein the second non-treatment period is from 26 to 30 days. 
     
     
         15 . A method of  claim 2  wherein the treatment regime of the first treatment period followed by the second non-treatment period is repeated a multiplicity of times. 
     
     
         16 . A method of  claim 2  wherein the powder comprises particles at least 50% of which have an aerodynamic diameter in the range of from 1 μm to 5 μm. 
     
     
         17 . A method of  claim 2  wherein the patient is a cystic fibrosis patient. 
     
     
         18 . A method of  claim 17  wherein the cystic fibrosis patient is suffering from a  Pseudomonas  endobronchial infection. 
     
     
         19 . A method of  claim 1  wherein the aerosol powder is administered to the patient using a dry powder inhaler. 
     
     
         20 . A method of  claim 1  wherein the aerosol powder is disposed within a single container within the dry powder inhaler, and the aerosol powder is delivered from the container into the lungs of the human or animal subject by the inhaler. 
     
     
         21 . A method of  claim 20  wherein the aerosol powder is disposed within multiple containers within the dry powder inhaler, and the aerosol powder is delivered from the containers into the lungs of the human or animal subject by the inhaler. 
     
     
         22 . A method for the treatment of a cystic fibrosis patient suffering from an endobronchial infection, comprising administering to endobronchial system of the patient a dry powder aerosol composition comprising from 110 to 115 mg of tobramycin antibiotic twice a day for a first treatment period of 28 days, providing a second non-treatment period of from 26 to 30 days wherein no tobramycin antibiotic is administered to the endobronchial system of the patient, and then repeating the first and second treatment periods. 
     
     
         23 . A method of  claim 22  wherein the aerosol powder composition administered to the patient is divided into three to five unit doses. 
     
     
         24 . A method of  claim 23  wherein the aerosol powder composition is divided into four unit doses. 
     
     
         25 . A method of  claim 22  wherein the cystic fibrosis patient is suffering from a  Pseudomonas  endobronchial infection. 
     
     
         26 . A method of  claim 22  wherein the first and second treatment periods are repeated a multiplicity of times.