Compositions and methods for treating cystic fibrosis

Abstract

A method of treating or preventing cystic fibrosis in a patient in need of such treatment, the method comprising administering to the patient a therapeutically effective amount of an LTB 4 antagonist of formula (I) or a tautomer thereof.

We claim:  
     
         1 . A method of treating or preventing cystic fibrosis in a patient in need of such treatment, the method comprising administering to the patient a therapeutically effective amount of an LTB 4  antagonist of formula (I)  
       
         
           
           
               
               
           
         
       
       or a tautomer thereof.  
     
     
         2 . The method according  claim 1 , wherein the therapeutically effective amount of an LTB 4  antagonist of formula (I) is between 5 mg to 200 mg.  
     
     
         3 . The method according to  claim 1 , wherein an additional active ingredient selected from the group consisting of antibiotics, LTA 4  hydrolase inhibitors, 5-lipoxygenase inhibitors, and agents that enhance mucus clearance, are administered simultaneously or sequentially with the LTB 4  antagonist of formula (I).  
     
     
         4 . The method according to  claim 2 , wherein an additional active ingredient selected from the group consisting of antibiotics, LTA 4  hydrolase inhibitors, 5-lipoxygenase inhibitors, and agents that enhance mucus clearance, are administered simultaneously or sequentially with the LTB 4  antagonist of formula (I).  
     
     
         5 . The method according to  claim 1 , wherein an additional active ingredient selected from the group consisting of aminoglycoside antibiotics, antibacterial peptides derived from or related to the structure of defensins, and agents which inhibit the production or action of neutrophil elastase, are administered simultaneously or sequentially with the LTB 4  antagonist of formula (I).  
     
     
         6 . The method according to  claim 2 , wherein an additional active ingredient selected from the group consisting of aminoglycoside antibiotics, antibacterial peptides derived from or related to the structure of defensins, and agents which inhibit the production or action of neutrophil elastase, are administered simultaneously or sequentially with the LTB 4  antagonist of formula (I).  
     
     
         7 . The method according to  claim 1 , wherein an additional active ingredient selected from the group consisting of atreleuton, zileuton, FK-706, CE 1037, EPI-HNE-4, alpha 1-antitrypsin, ambroxol, gentamycin, amikacin, kanamycin, streptomycin, neomycin, netimicin, colistin, iseganan, and tobramycin are administered simultaneously or sequentially with the LTB 4  antagonist of formula (I).  
     
     
         8 . The method according to  claim 2 , wherein an additional active ingredient selected from the group consisting of atreleuton, zileuton, FK-706, CE 1037, EPI-HNE-4, alpha 1-antitrypsin, ambroxol, gentamycin, amikacin, kanamycin, streptomycin, neomycin, netimicin, colistin, iseganan, and tobramycin are administered simultaneously or sequentially with the LTB 4  antagonist of formula (I).  
     
     
         9 . The method according to  claim 1 , wherein the LTB 4  antagonist of formula (I) is administered orally.  
     
     
         10 . The method according to  claim 2 , wherein the LTB 4  antagonist of formula (I) is administered orally.  
     
     
         11 . The method according to  claim 3 , wherein the LTB 4  antagonist of formula (I) and the additional active ingredient are administered orally.  
     
     
         12 . The method according to  claim 4 , wherein the LTB 4  antagonist of formula (I) and the additional active ingredient are administered orally.  
     
     
         13 . The method according to  claim 5 , wherein the LTB 4  antagonist of formula (I) and the additional active ingredient are administered orally.  
     
     
         14 . The method according to  claim 6 , wherein the LTB 4  antagonist of formula (I) and the additional active ingredient are administered orally.  
     
     
         15 . The method according to  claim 7 , wherein the LTB 4  antagonist of formula (I) and the additional active ingredient are administered orally.  
     
     
         16 . The method according to  claim 8 , wherein the LTB 4  antagonist of formula (I) and the additional active ingredient are administered orally.  
     
     
         17 . A medicament comprising: 
 (A) an LTB 4  antagonist of formula (I)                          or a tautomer thereof;    (B) one or more additional active ingredients selected from the group consisting of antibiotics, LTA 4  hydrolase inhibitors, 5-lipoxygenase inhibitors, and agents that enhance mucus clearance; and    (C) optionally a pharmaceutically acceptable carrier.    
     
     
         18 . A medicament according to  claim 17 , wherein the weight ratio of (A) to (B) is from 100:1 to 1:200.  
     
     
         19 . A pharmaceutical kit comprising at least two separate unit dosage forms (A) and (B): 
 (A) an LTB 4  antagonist of formula (I)                          or a tautomer thereof, and optionally a pharmaceutically acceptable carrier; and    (B) one or more additional active ingredients selected from the group consisting of antibiotics, LTA 4  hydrolase inhibitors, 5-lipoxygenase inhibitors, and agents that enhance mucus clearance, and optionally a pharmaceutically acceptable carrier.    
     
     
         20 . A pharmaceutical kit comprising at least two separate containers (A) and (B), (A) and (B) comprising: 
 (A) an LTB 4  antagonist of formula (I)                          or a tautomer thereof, and optionally a pharmaceutically acceptable carrier; and    (B) one or more additional active ingredients selected from the group consisting of antibiotics, LTA 4  hydrolase inhibitors, 5-lipoxygenase inhibitors, and agents that enhance mucus clearance, and optionally a pharmaceutically acceptable carrier.