Novel composition and method for treatment of upper respiratory conditions

Abstract

Provided are compositions and methods useful for the non-addictive treatment and prevention of upper respiratory conditions in man and animals, e.g., allergic, non-allergic and mixed rhinitis in man or pharyngitis and IAD in horses. Compositions of the invention comprise effective amounts of a suitable nasal decongestant; a suitable corticosteroid; and a suitable anticholinergic agent. The compositions and methods provided are especially useful for long term use in patients with mixed rhinitis and substantially reduce or eliminate the risk of rhinitis medicamentosa. The compositions and methods of treatment provided also eliminate the risk of adverse sequella seen from therapeutic regimens which employ systemic use of decongestants. The compositions provided can further comprise a suitable aromatic and/or a suitable antihistamine and may also comprise optional suitable antimicrobials, cytokine modulators, leukotriene antagonists, cromolyn sodium, or a suitable NDAID agent.

What is claimed is:  
     
         1 . A composition useful for the non-addictive treatment and/or prevention of an upper airway condition in a subject, the composition comprising effective amounts of a suitable nasal decongestant; a suitable corticosteroid; and a suitable anticholinergic agent.  
     
     
         2 . The composition of  claim 1 , wherein the subject is a human.  
     
     
         3 . The composition of  claim 2 , wherein the upper airway condition is rhinitis.  
     
     
         4 . The composition of  claim 3 , wherein the rhinitis is selected from the group consisting of allergic rhinitis, non-allergic rhinitis and mixed rhinitis.  
     
     
         5 . The composition of  claim 1 , wherein the subject is an animal.  
     
     
         6 . The composition of  claim 5 , wherein the animal is selected from the group consisting of a horse, a dog and a cat.  
     
     
         7 . The composition of  claim 6 , wherein the animal is a horse and the upper airway condition is pharyngitis.  
     
     
         8 . The composition of  claim 1 , wherein the composition is a liquid.  
     
     
         9 . The composition of  claim 8 , wherein the composition is a liquid and at least a selected one of the suitable nasal decongestant, the suitable corticosteroid or the suitable anticholinergic agent is in solution in the composition.  
     
     
         10 . The composition of  claim 1 , wherein the suitable nasal decongestant is selected from the group consisting of oxymetazoline hydrochloride, phenylephrine hydrochloride, phenylpropolamine hydrochloride, pseudophedrine and combinations thereof.  
     
     
         11 . The composition of  claim 10 , wherein the suitable nasal decongestant is oxymetazoline hydrochloride and the effective amount is from between about 0.25 ml to about 4.0 ml of a 0.05% solution of oxymetazoline hydrochloride.  
     
     
         12 . The composition of  claim 11 , wherein the effective amount is about 2.0 ml of a 0.05% solution of oxymetazoline hydrochloride.  
     
     
         13 . The composition of  claim 1 , wherein the suitable corticosteroid is selected from the group consisting of betamethazone dipropionate, flunisolide, triamcinolone acetate, fluticasone propionate and hydrocortisone.  
     
     
         14 . The composition of  claim 13 , wherein the suitable corticosteroid is triamcinolone acetate and the effective amount is from between about 3.0 ml to about 24.0 ml of a 0.25 gram/ml solution of triamcinolone acetate.  
     
     
         15 . The composition of  claim 14 , wherein the effective amount is about 6.0 ml of a 0.25 gram/ml solution of triamcinolone acetate.  
     
     
         16 . The composition of  claim 13 , wherein the suitable corticosteroid is betamethasone dipropionate and the effective amount is from between about 3.0 ml to about 24.0 ml of a 84 meq/0.1 ml solution of betamethasone dipropionate.  
     
     
         17 . The composition of  claim 16 , wherein the effective amount is about 6 ml of a 84 meq/0.1 ml solution of betamethasone dipropionate.  
     
     
         18 . The composition of  claim 13 , wherein the suitable corticosteroid is budesonide and the effective amount is from between about 3.0 ml to about 24.0 ml of a 384 meq/ml solution of budesonide.  
     
     
         19 . The composition of  claim 18 , wherein the effective amount is about 5 ml of a 384 meq/ml solution of budesonide.  
     
     
         20 . The composition of  claim 13 , wherein the suitable corticosteroid is flunisolide and the effective amount is from between about 3.0 ml to about 24.0 ml of a 0.025% solution of flunisolide.  
     
     
         21 . The composition of  claim 20 , wherein the effective amount is about 11 ml of a 0.025% solution of flunisolide.  
     
     
         22 . The composition of  claim 13 , wherein the suitable corticosteroid is fluticasone propionate and the effective amount is from between about 3.0 ml to about 24.0 ml of a 100 meq/ml solution of fluticasone propionate.  
     
     
         23 . The composition of  claim 22 , wherein the effective amount is about 10 ml of a fluticasone propionate solution such that the final concentration of fluticasone propionate in the composition is about 100 meq/0.10 ml.  
     
     
         24 . The composition of  claim 13 , wherein the suitable corticosteroid is mometasone furonate monohydrate and the effective amount is from between about 5.0 ml to about 40.0 ml of a 0.05% solution of mometasone furonate monohydrate.  
     
     
         25 . The composition of  claim 24 , wherein the effective amount is about 10 ml of a 0.05% solution of mometasone furonate monohydrate such that the final concentration of mometasone furonate monohydrate in the composition is about 100 meq/0.10 ml.  
     
     
         26  The composition of  claim 1 , wherein the suitable anticholinegic agent is selected from the group consisting of atropine, scopolomine, ipratropium bromide and combinations thereof.  
     
     
         27 . The composition of  claim 26 , wherein the suitable anticholinergic agent is ipratropium bromide and the effective amount is from between about 1.25 ml to about 12.0 ml of a 42 meq/ml solution of ipratropium bromide.  
     
     
         28 . The composition of  claim 27 , wherein the effective amount is about 5 ml of a 42 meq/ml solution of ipratropium bromide.  
     
     
         29 . The composition of  claim 1 , further comprising an effective amount of a suitable antihistamine.  
     
     
         30 . The composition of  claim 30 , wherein the suitable antihistamine is selected from the group consisting of cetirizine, chlorpheniramine, diphenhydramine, dexchloropheniramine, astemizole, azelastine hydrochloride, acrivastine, loratadine, terfenadine, cyproheptidine and combinations thereof.  
     
     
         31 . The composition of  claim 30 , wherein the suitable antihistamine is azelastine hydrochloride and the effective amount is from between about 1.25 ml to about 7.5 ml of a 0.1% solution of azelastine hydrochloride.  
     
     
         32 . The composition of  claim 31 , wherein the effective amount is about 5 ml of a 0.1% solution of azelastine hydrochloride.  
     
     
         33 . The composition of  claim 1 , further comprising an effective amount of a suitable antimicrobial agent.  
     
     
         34 . The composition of  claim 33 , wherein the suitable antimicrobial agent is selected from the group consisting of an antibiotic, an antibacterial, an antifungal, an antiviral and combinations thereof.  
     
     
         35 . The composition of  claim 1 , further comprising an effective amount of a suitable cytokine modulator.  
     
     
         36  The composition of  claim 35 , wherein the cytokine modulator is selected from the group consisting of pimecrolimus, tacrolimus, zileuton and combinations thereof.  
     
     
         37 . The composition of  claim 1 , further comprising an effective amount of a suitable antileukotriene or a leukotriene receptor antagonist.  
     
     
         38 . The composition of  claim 37 , wherein the suitable leukotriene receptor antagonist is selected from the group consisting of montelukast sodium, zafirulakast and combinations thereof.  
     
     
         39 . The composition of  claim 1 , further comprising an effective amount of cromolyn sodium.  
     
     
         40 . The composition of  claim 1 , further comprising an effective amount of nedocromil sodium.  
     
     
         41 . The composition of  claim 1 , further comprising an effective amount of a suitable non-steroidal anti-inflammatory agent.  
     
     
         42 . The composition of  claim 41 , wherein the suitable non-steroidal anti-inflammatory agent is selected from the group consisting of acetominophen, ibuprofen, ketofen, rofecoxib, celecoxib, flunixin meglumine and combinations thereof.  
     
     
         43 . The composition of  claim 1 , wherein a suitable non-steroidal anti-inflammatory agent is substituted for the suitable corticosteroid in the composition.  
     
     
         44 . The composition of  claim 1 , further comprising an effective amount of a suitable aromatic agent.  
     
     
         45 . The composition of  claim 44 , wherein the suitable aromatic agent is selected from the group consisting of camphor, menthol, eucalyptus and combinations thereof.  
     
     
         46 . A method for the non-addictive treatment and/or prevention of an upper airway condition in a subject comprising administering to the subject an effective amount of a composition comprised of effective amounts of a suitable nasal decongestant; a suitable corticosteroid; and a suitable anticholinergic agent.  
     
     
         47 . The method of  claim 46 , wherein the subject is a human.  
     
     
         48 . The method of  claim 47 , wherein the upper airway condition is rhinitis.  
     
     
         49 . The method of  claim 48 , wherein the rhinitis is selected from the group consisting of allergic rhinitis, non-allergic rhinitis and mixed rhinitis.  
     
     
         50 . The method of  claim 46 , wherein the subject is an animal.  
     
     
         51 . The method of  claim 50 , wherein the animal is selected from the group consisting of a horse, a dog and a cat.  
     
     
         52 . The method of  claim 51 , wherein the animal is a horse and the upper airway condition is pharyngitis.  
     
     
         53 . The method of  claim 46 , wherein the composition is administered topically.  
     
     
         54 . The method of  claim 46 , wherein the composition is administered intranasally.  
     
     
         55 . The method of  claim 46 , wherein the composition further comprises an effective amount of a suitable antihistamine.  
     
     
         56 . The method of  claim 46 , wherein the composition further comprises an effective amount of a suitable antimicrobial agent.  
     
     
         57 . The method of  claim 46 , wherein the composition further comprises an effective amount of a suitable cytokine modulator.  
     
     
         58 . The method of  claim 46 , wherein the composition further comprises an effective amount of a suitable antileukotriene or a leukotriene receptor antagonist.  
     
     
         59 . The method of  claim 46 , wherein the composition further comprises an effective amount of cromolyn sodium.  
     
     
         60 . The method of  claim 46 , wherein the composition further comprises an effective amount of nedocromil sodium.  
     
     
         61 . The method of  claim 46 , wherein the composition further comprises an effective amount of a suitable non-steroidal anti-inflammatory agent.  
     
     
         62 . The method of  claim 46 , wherein a suitable non-sterioidal anti-inflammatory agent is substituted for the suitable corticosteroid in the composition.  
     
     
         63 . The method of  claim 46 , wherein the composition further comprises an effective amount of a suitable aromatic agent.