Treatment of Rhinitis

Abstract

The invention provides a method of treating rhinitis. The method comprises administering an effective amount of a pharmaceutical composition comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP) formulated for nasal administration. The invention also provides a pharmaceutical product comprising a DA-DKP containing composition.

1 - 36 . (canceled) 
     
     
         37 . A method of treating rhinitis, comprising administering a pharmaceutical composition comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP), to an animal. 
     
     
         38 . The method of  claim 37 , wherein the rhinitis is selected from the group consisting of infectious rhinitis, allergic rhinitis, and nonallergic rhinitis. 
     
     
         39 . The method of  claim 37 , wherein the rhinitis is infectious rhinitis caused by viral infection. 
     
     
         40 . The method of  claim 37 , wherein the DA-DKP is in a composition prepared by removing albumin from a solution of a human serum albumin composition by passing the human serum albumin composition over an ultrafiltration membrane with a molecular weight cut off that retains the albumin, and wherein the resulting filtrate comprises DA-DKP, wherein the ultrafiltration membrane has molecular weight cutoff of less than 50 kDa, less than 40 kDa, less than 30 kDa, less than 20 kDa, less than 10 kDa, less than 5 kDa or less than 3 kDa. 
     
     
         41 . The method of  claim 37 , wherein the pharmaceutical composition is administered in combination with a second drug selected from the group consisting of an antihistamine, a decongestant, an anti-inflammatory, a mast cell stabilizer, a leukotriene modifier, and an IgE blocker. 
     
     
         42 . The method of  claim 37 , wherein the pharmaceutical composition is formulated for administration to the nose by inhalation, insufflation or nasal administration via a device selected from the group consisting of an inhalator, insufflator, nebulizer, and metered-dose inhaler. 
     
     
         43 . The method of  claim 37 , wherein the pharmaceutical composition is formulated for administration by inhalation and is packaged in a device selected from the group consisting of insufflators, nebulizers, pressurized packs, squeeze bottle, a syringe, a dropper, a spray device, an atomizer device, and an aerosolizer. 
     
     
         44 . The method of  claim 37 , wherein the pharmaceutical composition is formulated for nasal administration and is in a form of drops or sprays contained within an intranasal delivery system comprising an atomizing device. 
     
     
         45 . The method of  claim 37 , wherein the pharmaceutical composition is formulated for nasal administration and is in a form selected from the group consisting of ointments, gels and creams, wherein the composition further comprises an absorption or permeation enhancer and/or a thickening agent or viscosity enhancer to increase the residence time of the DA-DKP containing composition in the nose. 
     
     
         46 . The method of  claim 37 , wherein the DA-DKP comprises from about 0.1% (w/v) to about 10% (w/v) of the composition. 
     
     
         47 . A method of treating inflammation of the mucous membranes of the nose, comprising administering a pharmaceutical composition comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP), to an animal. 
     
     
         48 . The method of  claim 47 , wherein the rhinitis is selected from the group consisting of infectious rhinitis, allergic rhinitis, and nonallergic rhinitis. 
     
     
         49 . The method of  claim 47 , wherein the rhinitis is infectious rhinitis caused by viral infection. 
     
     
         50 . The method of  claim 47 , wherein the DA-DKP is in a composition prepared by removing albumin from a solution of a human serum albumin composition by passing the human serum albumin composition over an ultrafiltration membrane with a molecular weight cut off that retains the albumin, and wherein the resulting filtrate comprises DA-DKP, wherein the ultrafiltration membrane has molecular weight cutoff of less than 50 kDa, less than 40 kDa, less than 30 kDa, less than 20 kDa, less than 10 kDa, less than 5 kDa or less than 3 kDa. 
     
     
         51 . The method of  claim 47 , wherein the pharmaceutical composition is administered in combination with a second drug selected from the group consisting of an antihistamine, a decongestant, an anti-inflammatory, a mast cell stabilizer, a leukotriene modifier, and an IgE blocker. 
     
     
         52 . The method of  claim 47 , wherein the pharmaceutical composition is formulated for administration to the nose by inhalation, insufflation or nasal administration via a device selected from the group consisting of an inhalator, insufflator, nebulizer, and metered-dose inhaler. 
     
     
         53 . The method of  claim 47 , wherein the pharmaceutical composition is formulated for administration by inhalation and is packaged in a device selected from the group consisting of insufflators, nebulizers, pressurized packs, squeeze bottle, a syringe, a dropper, a spray device, an atomizer device, and an aerosolizer. 
     
     
         54 . The method of  claim 47 , wherein the pharmaceutical composition is formulated for nasal administration and is in a form of drops or sprays contained within an intranasal delivery system comprising an atomizing device. 
     
     
         55 . The method of  claim 47 , wherein the pharmaceutical composition is formulated for nasal administration and is in a form selected from the group consisting of ointments, gels and creams, wherein the composition further comprises an absorption or permeation enhancer, and/or a thickening agent or viscosity enhancer to increase the residence time of the DA-DKP containing composition in the nose. 
     
     
         56 . The method of  claim 47 , wherein the DA-DKP comprises from about 0.1% (w/v) to about 10% (w/v) of the composition.