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 safe and well-tolerated method of treating rhinosinusitis in the nasal passages of a patient comprising: administering rhCClO to the patient. 
     
     
         2 . The method of  claim 1  wherein the amount of rhCClO administered is between about 1.5 micrograms and about 1.5 milligrams per day. 
     
     
         3 . The method of  claim 1  wherein the amount of rhCClO administered is less than about 1.1 milligrams per day. 
     
     
         4 . The method of  claim 1  wherein the amount of rhCClO that is administered is about 0.75 micrograms to about 650 micrograms per day. 
     
     
         5 . The method of  claim 1  wherein the amount of rhCClO that is administered is about 0.5 micrograms to about 370 micrograms per day. 
     
     
         6 . The method of  claim 1  wherein the administration of rhCClO is repeated about three times per day. 
     
     
         7 . The method of  claim 1  wherein the administration of rhCClO is repeated about two days. 
     
     
         8 . The method of  claim 1  wherein rhCClO is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
         9 . The method of  claim 1  wherein rhCClO 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. 
     
     
         10 . A safe and well-tolerated method of preventing or slowing growth or regrowth of nasal polyps in a patient comprising: administering rhCClO to the patient. 
     
     
         11 . The method of  claim 10  wherein rhCC 10 between about 1.5 micrograms and 1.5 milligrams is administered each day for at least 2 days. 
     
     
         12 . The method of  claim 10  wherein the amount of rhCClO that is administered is 1.1 milligrams per day or less. 
     
     
         13 . The method of  claim 10  wherein the administration of rhCClO is repeated about three times per day. 
     
     
         14 . The method of  claim 10  wherein rhCClO is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
         15 . The method of  claim 10  wherein rhCClO 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. 
     
     
         16 . A safe and well-tolerated method of treating or preventing chronic or recurrent bacterial sinus infection in a patient comprising: administering rhCClO to the patient. 
     
     
         17 . The method of  claim 16  wherein rhCClO between about 1.5 micrograms and 1.5 milligrams is administered each day for at least 2 days. 
     
     
         18 . The method of  claim 16  wherein the amount of rhCC 10 that is administered is 1.1 milligrams per day or less. 
     
     
         19 . The method of  claim 16  wherein the administration of rhCClO is repeated about three times per day. 
     
     
         20 . The method of  claim 16  wherein rhCClO is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
         21 . The method of  claim 16  wherein rhCClO 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. 
     
     
         22 . A safe and well-tolerated method of treating sinus pain in a patient comprising: administering rhCClO to the patient. 
     
     
         23 . The method of  claim 22  wherein rhCClO between about 1.5 micrograms and 1.5 milligrams is administered each day for at least 2 days. 
     
     
         24 . The method of  claim 22  wherein the amount of rhCClO that is administered is 1.1 milligrams per day or less. 
     
     
         25 . The method of  claim 22  wherein the administration of rhCClO is repeated about three times per day. 
     
     
         26 . The method of  claim 22  wherein rhCClO is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
         27 . The method of  claim 22  wherein rhCC 10 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. 
     
     
         28 . A pharmaceutical composition for intranasal administration of rhCClO comprising a formulation comprising rhCClO in combination with a nasal excipient. 
     
     
         29 . The pharmaceutical composition of  claim 28  comprising rhCClO at a concentration no greater than 2 milligrams/milliliter. 
     
     
         30 . The pharmaceutical composition of  claim 28  comprising rhCClO 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. 
     
     
         31 . (canceled) 
     
     
         32 . A drug-device combination composition comprising the pharmaceutical composition of  claim 30  and a squeeze spray bottle, pump action spray device, metered dose nasal actuator, syringe-type instillation device, nasal swab applicator, or “Neti pot” lavage device that enables the topical application of rhCClO to the surfaces of the nasal passages. 
     
     
         33 . The method of  claim 1  wherein rhCClO is administered in a pharmaceutical composition comprising a formulation comprising rhCClO in combination with a nasal excipient wherein rhCC10 is present in a concentration no greater than 2 milligrams/milliliter in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
         34 . The method of  claim 10  wherein rhCClO is administered in a pharmaceutical composition comprising a formulation comprising rhCClO in combination with a nasal excipient wherein rhCC10 is present in a concentration no greater than 2 milligrams/milliliter in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
         35 . The method of  claim 16  wherein rhCClO is administered in a pharmaceutical composition comprising a formulation comprising rhCClO in combination with a nasal excipient wherein rhCC10 is present in a concentration no greater than 2 milligrams/milliliter in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
         36 . The method of  claim 20  wherein rhCClO is administered in a pharmaceutical composition comprising a formulation comprising rhCClO in combination with a nasal excipient wherein rhCC10 is present in a concentration no greater than 2 milligrams/milliliter in a dosage of 20-50 micrograms per nostril up to four times per day.