Use of aerosolized levofloxacin for treating cystic fibrosis

Abstract

Methods for treating cystic fibrosis. The method includes administering to a human in need thereof an aerosol solution comprising levofloxacin or ofloxacin and a divalent or trivalent cation. More particularly, the method includes administering the aerosol solution to a human having a pulmonary infection comprising P. aeruginosa.

1 .- 20 . (canceled) 
     
     
         21 . A method for treating a pulmonary infection, the method comprising:
 administering via inhalation 240 mg of levofloxacin twice daily for 28 days to the human having cystic fibrosis to treat the pulmonary infection;   wherein the levofloxacin is in an aerosol of a solution comprising levofloxacin at a concentration from about 90 mg/ml to about 110 mg/ml, a magnesium cation at a concentration from about 175 mM to about 225 mM, wherein the solution has a pH from about 5 to about 7, and an osmolality from about 300 mOsmol/kg to about 500 mOsmol/kg.   
     
     
         22 . The method of  claim 21 , wherein the pulmonary infection is a bacterial infection caused by  Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas acidovorans, Pseudomonas alcaligenes, Pseudomonas putida, Stenotrophomonas  sp., e.g.,  Stenotrophomonas maltophilia, Aeromonas hydrophilia, Escherichia coli, Citrobacter freundii, Salmonella typhimurium, Salmonella typhi, Salmonella paratyphi, Salmonella enteritidis, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia alcalifaciens, Providencia rettgeri, Providencia stuartii, Acinetobacter calcoaceticus, Acinetobacter haemolyticus, Yersinia enterocolitica, Yersinia pestis, Yersinia pseudotuberculosis, Yersinia intermedia, Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus haemolyticus, Haemophilus parahaemolyticus, Haemophilus ducreyi, Pasteurella multocida, Pasteurella haemolytica, Helicobacter pylori, Campylobacter fetus, Campylobacter jejuni, Campylobacter coli, Borrelia burgdorferi, Vibrio cholera, Vibrio parahaemolyticus, Legionella pneumophila, Listeria monocytogenes, Neisseria gonorrhoeae, Neisseria meningitidis, Burkholderia  sp., e.g.,  Burkholderia cepacia, Francisella tularensis, Kingella,  and  Moraxella. Mycobacterium  is  Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium intracellulare,  and  Mycobacterium leprae, Chlamydia pneumoniae, Mycoplasma pneumoniae    
     
     
         23 . The method of  claim 22 , wherein the bacterial infection caused by  Pseudomonas aeruginosa.    
     
     
         24 . The method of  claim 21 , wherein the magnesium cation is in the form of magnesium chloride. 
     
     
         25 . The method of  claim 21 , wherein the solution comprises a levofloxacin concentration of about 100 mg/ml, a magnesium chloride concentration of about 200 mM, a pH between about 6.0 to about 6.5, and an osmolality of between about 300 mOsmol/kg to about 500 mOsmol/kg, and lacks lactose. 
     
     
         26 . The method of  claim 21 , wherein the aerosol of the solution comprises a mass median aerodynamic diameter from about 2 microns to about 5 microns with a geometric standard deviation less than or equal to 2.5 microns. 
     
     
         27 . The method of  claim 21 , wherein the aerosol is produced by a vibrating mesh nebulizer. 
     
     
         28 . The method of  claim 21 , further comprising administering an antibiotic, a bronchodilator, an anticholinergic agent, a glucocorticoid, an eicosanoid inhibitor, or a combination of two or more thereof.