Cromolyn Compositions for Treatment of Pulmonary Fibrosis

Abstract

The disclosure provides a method of treating pulmonary fibrosis, including idiopathic pulmonary fibrosis, in a comprising administering to the subject a pharmaceutical composition comprising from about 1% by weight to about 99% by weight of cromolyn sodium with an inhalation device.

1 . A method of treating idiopathic pulmonary fibrosis in a subject, comprising:
 (a) measuring in the serum of the subject having pulmonary fibrosis the concentration of one or more of BGM, C1M, C3A, C3M, C5M, C6M, VICM, CRPM, FPA, and D-dimer; and   (b) administering to the subject having pulmonary fibrosis a pharmaceutical composition comprising from about 2% by weight to about 99% by weight of cromolyn sodium with an inhalation device if the subject is determined to have an increased serum concentration of one or more of BGM, C1M, C3A, C3M, C5M, C6M, VICM, CRPM, FPA, and D-dimer; and   (c) wherein the subject experiences a decline of forced vital capacity (% FVC) of less than about 10% following administration of the pharmaceutical composition.   
     
     
         2 . The method according to  claim 1 , wherein the inhalation device is a nebulizer, a high-efficiency nebulizer, or a dry-powder inhaler. 
     
     
         3 . The method according to  claim 2 , wherein the inhalation device is a nebulizer or a high-efficiency nebulizer. 
     
     
         4 . The method according to  claim 3 , wherein the nebulizer is a high-efficiency nebulizer. 
     
     
         5 . The method according to  claim 4 , wherein the high-efficiency nebulizer is a vibrating mesh nebulizer. 
     
     
         6 . The method according to  claim 4 , wherein the high-efficiency nebulizer is a jet nebulizer. 
     
     
         7 . The method according to  claim 2 , wherein the inhalation device is a dry-powder inhaler. 
     
     
         8 - 12 . (canceled) 
     
     
         13 . The method according to  claim 1 , wherein the subject experiences a decline of forced vital capacity (% FVC) of less than about 5% following administration of the pharmaceutical composition to the subject for at least 2 weeks. 
     
     
         14 - 17 . (canceled) 
     
     
         18 . The method according to  claim 1 , wherein the subject experiences no decline of forced vital capacity (% FVC) following administration of the pharmaceutical composition to the subject for at least 2 weeks. 
     
     
         19 . (canceled) 
     
     
         20 . The method according to  claim 1 , wherein the pharmaceutical composition comprises about 2%, about 4%, or about 6% by weight of cromolyn sodium. 
     
     
         21 - 24 . (canceled) 
     
     
         25 . The method according to  claim 20 , wherein the pharmaceutical composition does not comprise a sugar alcohol or propylene glycol. 
     
     
         26 - 30 . (canceled) 
     
     
         31 . A method of treating idiopathic pulmonary fibrosis in a subject, comprising:
 (a) administering to a subject having pulmonary fibrosis a pharmaceutical composition comprising from about 2% by weight to about 99% by weight of cromolyn sodium with an inhalation device; and   (c) wherein the subject experiences a decline of forced vital capacity (% FVC) of less than about 300 mL following administration of the pharmaceutical composition.   
     
     
         32 . The method according to  claim 31 , wherein the inhalation device is a nebulizer, a high-efficiency nebulizer, or a dry-powder inhaler. 
     
     
         33 . The method according to  claim 32 , wherein the inhalation device is a nebulizer or a high-efficiency nebulizer. 
     
     
         34 . The method according to  claim 33 , wherein the nebulizer is a high-efficiency nebulizer. 
     
     
         35 . The method according to  claim 33 , wherein the high-efficiency nebulizer is a vibrating mesh nebulizer. 
     
     
         36 . The method according to  claim 33 , wherein the nebulizer is a jet nebulizer. 
     
     
         37 . The method according to  claim 31 , wherein the inhalation device is a dry-powder inhaler. 
     
     
         38 . The method according to  claim 31 , wherein the subject experiences a decline of forced vital capacity (% FVC) of less than about 150 mL for about 2 weeks following administration of the pharmaceutical composition. 
     
     
         39 . The method according to  claim 31 , wherein the subject experiences no decline of forced vital capacity (% FVC) for about 2 weeks following administration of the pharmaceutical composition.