Cromolyn Compositions for Treatment of Chronic Cough Due to Idiopathic Pulmonary Fibrosis

Abstract

The disclosure provides a method of treating chronic cough in a subject having idiopathic pulmonary fibrosis (IPF) comprising administering to the subject a pharmaceutical composition comprising from about 2% by weight to about 6% by weight of cromolyn sodium and an ionic osmotic agent with a nebulizer.

1 .- 30 . (canceled) 
     
     
         31 . A method of reducing chronic cough in a subject having idiopathic pulmonary fibrosis, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising cromolyn, or a pharmaceutically acceptable salt thereof;
 with an inhalation device;   wherein the subject has been diagnosed as having idiopathic pulmonary fibrosis prior to administration of the pharmaceutical composition; and   wherein the 24 hour cough count decreases by about 10% to about 80%, relative to a baseline cough count.   
     
     
         32 . The method of  claim 31 , wherein the 24 hour cough count decreases by about 10% to about 70%, relative to a baseline cough count. 
     
     
         33 . The method of  claim 31 , wherein the 24 hour cough count decreases by about 10% to about 60%, relative to a baseline cough count. 
     
     
         34 . The method of  claim 31 , wherein the 24 hour cough count decreases by about 10% to about 50%, relative to a baseline cough count. 
     
     
         35 . The method of  claim 31 , wherein the 24 hour cough count decreases by about 10% to about 40%, relative to a baseline cough count. 
     
     
         36 . The method of  claim 31 , wherein the 24 hour cough count decreases by about 10% to about 30%, relative to a baseline cough count. 
     
     
         37 . The method of  claim 31 , wherein the 24 hour cough count decreases by about 10% to about 20%, relative to a baseline cough count. 
     
     
         38 . The method of  claim 31 , wherein the inhalation device is a nebulizer or a dry powder inhaler. 
     
     
         39 . The method of  claim 38 , wherein the inhalation device is a nebulizer. 
     
     
         40 . The method of  claim 39 , wherein the nebulizer is a jet nebulizer. 
     
     
         41 . The method of  claim 39 , wherein the nebulizer is a high-efficiency nebulizer. 
     
     
         42 . The method of  claim 41 , wherein the high-efficiency nebulizer is a vibrating mesh nebulizer. 
     
     
         43 . The method of  claim 38 , wherein the inhalation device is a dry powder inhaler. 
     
     
         44 . The method of  claim 31 , wherein the composition comprises a pharmaceutically acceptable salt of cromolyn. 
     
     
         45 . The method of  claim 44 , wherein the composition comprises cromolyn sodium. 
     
     
         46 . The method of  claim 31 , wherein the pharmaceutical composition comprises between about 2% and about 99% by weight of a pharmaceutically acceptable salt of cromolyn. 
     
     
         47 . The method of  claim 46 , wherein the composition comprises comprises between about 2% and about 99% by weight cromolyn sodium. 
     
     
         48 . The method according to  claim 31 , wherein the pharmaceutical composition is administered to the subject from once per day to five times per day. 
     
     
         49 . The method according to  claim 31 , wherein the pharmaceutical composition is administered to the subject three times per day. 
     
     
         50 . The method of  claim 38 , wherein administration of the pharmaceutical composition to the subject with the inhalation device provides in the subject a bioavailability of cromolyn between about 5% and about 60%. 
     
     
         51 . The method of  claim 38 , wherein each of the doses of the pharmaceutical composition comprises from about 10 mg to about 80 mg of cromolyn sodium, and administration of the pharmaceutical composition provides in the subject an AUC (0-∞)  of the cromolyn sodium of between about 100 ng*hr/mL and about 500 ng*hr/mL. 
     
     
         52 . The method of  claim 38 , wherein each of the doses of the pharmaceutical composition comprises from about 20 mg to about 80 mg of cromolyn sodium, and administration of the pharmaceutical composition provides in the subject a Cmax of the cromolyn sodium between about 50 ng/mL and about 230 ng/mL. 
     
     
         53 . The method of  claim 38 , wherein the nebulizer produces an aerosol of the pharmaceutical composition that exhibits a respirable fraction (≤5 μm) as measured by USP <1601> of between about 60% and about 90%.