Method of treating sinusitis, including chronic sinusitis

Abstract

The present invention relates to a method for treating acute and chronic sinusitis, and in particular, severe chronic sinusitis by exposing affected tissue of the sinus and contiguous tissue in the, nasal cavity and greater oral cavity to effective amounts of chlorine dioxide as a bioactive agent. Compositions and methods of treatment are disclosed herein.

1 . A method of treating inhibiting or reducing the likelihood of sinusitis in a patient or subject comprising administering to said patient or subject a composition comprising an effective amount of chlorine dioxide. 
     
     
         2 . The method according to  claim 1  wherein said composition comprises about 1 ppm to about 50 ppm chlorine dioxide. 
     
     
         3 . The method according to  claim 1  wherein said composition comprises about 5 ppm to about 30 ppm chlorine dioxide. 
     
     
         4 . (canceled) 
     
     
         5 . The method according to  claim 1  wherein said composition is administered to said patient or subject by exposing membranes of the sinus, nasal cavity and upper mouth to said composition. 
     
     
         6 . The method according to  claim 1  wherein said composition has a pH ranging from about 4.0 to about 6.5. 
     
     
         7 . The method according to  claim 1  wherein said composition is adapted for oral administration by gargling. 
     
     
         8 . The method according to  claim 1  wherein said composition is adapted for nasal administration. 
     
     
         9 . The method according to  claim 1  wherein said composition is adapted for use as a nasal spray. 
     
     
         10 . The method according to  claim 1  wherein said composition is adapted for use as a nasal inhaler. 
     
     
         11 . The method according to  claim 1  wherein said composition is adapted for use as a nasal lavage. 
     
     
         12 . The method according to  claim 1  wherein said composition is adapted for use as an aerosol. 
     
     
         13 . The method according to  claim 1  wherein said composition is adapted for use in a humidifier or steam inhaler. 
     
     
         14 . The method according to  claim 1  wherein said composition further comprises at least one agent selected from the group consisting of flavoring agents, wetting agents, mucus loosening agents, membrane coating agents, decongestants and mixtures thereof. 
     
     
         15 . The method according to  claim 14  wherein said mucus loosening agent is sodium carbonate, sodium bicarbonate, guaifenesin or mixtures thereof. 
     
     
         16 . The method according to  claim 14  wherein said membrane coating agent is glycerin. 
     
     
         17 . The method according to  claim 1  wherein said sinusitis is acute sinusitis. 
     
     
         18 . The method according to  claim 1  wherein said sinusitis is chronic sinusitis. 
     
     
         19 . The method according to  claim 1 , wherein nasal and mouth tissue of the patient or subject is also exposed to the composition in order to reduce the likelihood of a recurrence of sinusitis from a cold or sore throat. 
     
     
         20 . A method of treating or inhibiting sinusitis according to  claim 1  in a patient or subject, wherein said chlorine dioxide being is produced by combining a first aqueous solution comprising an acid and a disproportionation agent and a second aqueous solution comprising a salt of chlorite, said composition, after combining said first and second solution, having a pH of about 4.0 to about 6.5. 
     
     
         21 . The method according to  claim 20  wherein said chlorine dioxide is produced at a concentration of about 1 ppm to about 50 ppm. 
     
     
         22 . The method according to  claim 20  wherein said chlorine dioxide is produced at a concentration of about 5 ppm to about 30 ppm chlorine dioxide. 
     
     
         23 .- 31 . (canceled) 
     
     
         32 . The method according to  claim 20  wherein said composition further comprises at least one agent selected from the group consisting of flavoring agents, wetting agents, mucus loosening agents, membrane coating agents, decongestants and mixtures thereof. 
     
     
         33 . The method according to  claim 32  wherein said mucus loosening agent is sodium carbonate, sodium bicarbonate, guaifenesin or a mixture thereof. 
     
     
         34 . (canceled) 
     
     
         35 . (canceled) 
     
     
         36 . (canceled) 
     
     
         37 . The method according to  claim 20  wherein said acid is selected from the group consisting of citric, fumaric, glycolic, lactic, maleic, malic, tartaric, mandelic, sodium bisulfate, potassium bisulfate, phosphoric acid and mixtures thereof. 
     
     
         38 . The method according to  claim 20  wherein said acid is lactic acid or a mixture of lactic acid and at least one additional acid. 
     
     
         39 . The method according to  claim 20  wherein said disproportionation agent is a hydroxyl free aldehyde and said pH is about 4.5 to about 6.5. 
     
     
         40 . The method according to  claim 20  wherein said disproportionation agent is selected from the group consisting of acetaldehyde, cinnamic aldehyde, propionaldehyde or a mixture thereof and said pH is about 5.0 to about 6.0. 
     
     
         41 . The method according to  claim 20  wherein said disproportionation agent is cinnamic aldehyde or a mixture of cinnamic aldehyde and priopionaldehyde at a pH of about 4.5 to about 6.0. 
     
     
         42 . (canceled) 
     
     
         43 . A kit comprising:
 a. a part A composition comprising an aqueous solution of acid;   b. a part B composition comprising an aqueous solution of a salt of chlorite;   c. at least one measuring cup with marks to indicate predetermined volume(s);   d. an optional mixing utensil;   e. an optional mixing cup; and   f. a nasal spray bottle.   
     
     
         44 . The kit according to  claim 43  wherein said acid solution further comprising a disproportionation agent. 
     
     
         45 .- 58 . (canceled) 
     
     
         59 . A composition exhibiting substantially the same concentration of chlorine dioxide within the range of about 10 to 20 ppm after initial formation for a period of at least a day, said composition comprising ribose within the range of about 0.05 to about 0.1% by weight, cinnamic aldehyde within the range of about 0.05% to about 0.15%, chlorite within the range of about 0.1% to about 0.3% and a pH within the range of about 5.0 to about 6.5. 
     
     
         60 . The composition according to  claim 59  wherein said ribose comprises about 0.075% by weight of said composition, said cinnamic aldehyde comprises about 0.1% by weight of said composition, said chlorite comprises about 0.2% by weight of said composition and said pH is within the range of about 5.5 to about 6.5, the amount of said chlorine dioxide falling within the range of about 14 to about 20 ppm for up to two days. 
     
     
         61 . The composition according to  claim 60  wherein said chlorine dioxide is maintained at a concentration of about 14 to 17 ppm for a period of up to three days. 
     
     
         62 .- 68 . (canceled) 
     
     
         69 . The method according to  claim 1  wherein said patient or subject is at risk for sinusitis because of allergies, asthma or the age of the patient or subject.