Methods and Compositions for Treating Idiopathic Pulmonary Fibrosis

Abstract

Provided is a pharmaceutical composition comprising an effective amount of itraconazole, and a pharmaceutically acceptable excipient. The use of the pharmaceutical composition for treatment of idiopathic pulmonary fibrosis is also provided.

We claim: 
     
         1 . A method for treating idiopathic pulmonary fibrosis, comprising administering to a patient in need thereof, a pharmaceutical composition comprising an effective amount of itraconazole, and a pharmaceutically acceptable excipient. 
     
     
         2 . The method of  claim 1 , wherein a daily dose of itraconazole in the range of 20 mg to 1200 mg is administered to the patient. 
     
     
         3 . The method of  claim 1 , wherein a daily dose of itraconazole of 1 mg/kg to 20 mg/kg bodyweight is administered to the patient. 
     
     
         4 . The method of  claim 1 , wherein itraconazole is administered by means of an oral, parenteral, rectal, cutaneous, nasal, vaginal, or inhalant route. 
     
     
         5 . The method of  claim 1 , wherein itraconazole is administered in combination with an effective amount of another antifibrosis agent. 
     
     
         6 . The method of  claim 5 , wherein the antifibrosis agent is pirfenidone or nintedanib. 
     
     
         7 . A pharmaceutical composition for treating IPF comprising an effective amount of itraconazole, and a pharmaceutically acceptable excipient comprises. 
     
     
         8 . The pharmaceutical composition of  claim 7 , comprising an amount of itraconazole in the range of 20 mg to 1200 mg. 
     
     
         9 . The pharmaceutical composition of  claim 7 , further comprising a pharmaceutically effective amount of another antifibrosis agent. 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the antifibrosis agent is pirfenidone or nintedanib. 
     
     
         11 . A dosage form for delivering itraconazole for treating IPF in a patient in need thereof, wherein the dosage form directly delivers an effective amount of itraconazole into the lungs of the patient. 
     
     
         12 . The dosage form of  claim 11 , wherein it delivers less than about 1/10 of an oral dosage for to the patient. 
     
     
         13 . The dosage form of  claim 11 , wherein the dosage form is a spray or a nebulizer. 
     
     
         14 . The dosage form of  claim 13 , further comprising a pharmaceutically effective amount of an antifibrosis agent. 
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein the antifibrosis agent is pirfenidone or nintedabib.