Recombinant human cc10 and compositions thereof for use in the treatment of nasal rhinitis

Abstract

The present invention relates generally to the use of recombinant human CC10 (rhCC10), also known as recombinant human uteroglobin, for use as a therapeutic in the treatment of nasal rhinitis, nasal sinusitis, chronic rhinosinusitis, and nasal polyposis. More particularly, the invention provides methods, including broadly the critical dosage ranges of rhCC10 and intranasal route of administration, which may be administered to safely and effectively treat the aforementioned conditions. The invention further provides a composition useful in administering rhCC10 to humans.

1 . A method of treating rhinosinusitis caused by infection in the nasal passages of a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
         2 . The method of  claim 1  wherein the amount of rhCC10 administered is between 0.5 micrograms and 1.5 milligrams per day. 
     
     
         3 . The method of  claim 1  wherein the rhCC10 is administered more than one time per day. 
     
     
         4 . The method of  claim 1  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, spray, squeeze spray bottle, pump action spray device, metered dose nasal actuator, syringe-type instillation device, or “Neti pot” lavage. 
     
     
         5 . The method of  claim 1  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
         6 . The method of  claim 1  compromising: administering rhCC10 at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
         7 . A method of preventing or slowing growth or regrowth of nasal polyps caused by infection in a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
         8 . The method of  claim 7  wherein the amount of rhCC10 administered is between 0.5 micrograms and 1.5 milligrams per day. 
     
     
         9 . The method of  claim 7  wherein the rhCC10 is administered more than one time per day. 
     
     
         10 . The method of  claim 7  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, spray, squeeze spray bottle, pump action spray device, metered dose nasal actuator, syringe-type instillation device, or “Neti pot” lavage. 
     
     
         11 . The method of  claim 7  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
         12 . The method of  claim 7  compromising: administering rhCC10 at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
         13 . A method of treating or preventing chronic or recurrent bacterial sinus infection in a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
         14 . The method of  claim 13  wherein the amount of rhCC10 administered is between 0.5 micrograms and 1.5 milligrams per day. 
     
     
         15 . The method of  claim 13  wherein the rhCC10 is administered more than one time per day. 
     
     
         16 . The method of  claim 13  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, spray, squeeze spray bottle, pump action spray device, metered dose nasal actuator, syringe-type instillation device, or “Neti pot” lavage. 
     
     
         17 . The method of  claim 13  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
         18 . The method of  claim 13  compromising: administering rhCC10 at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
         19 . A method of treating sinus pain caused by infection in a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
         20 . The method of  claim 19  wherein the amount of rhCC10 administered is between 0.5 micrograms and 1.5 milligrams per day. 
     
     
         21 . The method of  claim 19  wherein the rhCC10 is administered more than one time per day. 
     
     
         22 . The method of  claim 19  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, spray squeeze spray bottle, pump action spray device, metered dose nasal actuator, syringe-type instillation device, or “Neti pot” lavage. 
     
     
         23 . The method of  claim 19  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
         24 . The method of  claim 19  compromising: administering rhCC10 at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0.