Fluticasone furoate in the treatment of copd

Abstract

The present invention relates to a method of reducing the rate of decline in lung function in a human patient with COPD, wherein the human patient having COPD has a blood eosinophil count of ≥150 cells/μL, and further wherein the method comprises administering to the patient an inhaled pharmaceutical product comprising fluticasone furoate.

1 - 18 . (canceled) 
     
     
         19 . A method of reducing the rate of decline in lung function in a human patient with COPD, wherein the patient having COPD has a blood eosinophil count of ≥150 cells/μL, and further wherein the method comprises administering to the patient an inhaled pharmaceutical product comprising fluticasone furoate. 
     
     
         20 . The method of  claim 19 , wherein the inhaled pharmaceutical product comprises a dry powder inhaler, said dry powder inhaler comprising one or more dry powder compositions. 
     
     
         21 . The method of  claim 20 , wherein said one or more dry powder-compositions are in unit-dose form. 
     
     
         22 . The method of  claim 21 , wherein fluticasone furoate is present in an amount of about 100 mcg/dose. 
     
     
         23 . The method of  claim 22 , wherein the inhaled pharmaceutical product further comprises lactose monohydrate. 
     
     
         24 . The method of  claim 19 , wherein the inhaled pharmaceutical product further comprises umeclidinium bromide. 
     
     
         25 . The method of  claim 24 , wherein the inhaled pharmaceutical product-comprises a dry powder inhaler, wherein said dry powder inhaler comprises one or more dry powder compositions. 
     
     
         26 . The method of  claim 25 , wherein said one or more dry powder compositions are present in unit-dose form. 
     
     
         27 . The method of  claim 26 , wherein said fluticasone furoate is present in an amount of about 100 mcg/dose, and said umeclidinium bromide is present in an amount of about 62.5 mcg (of the free cation)/dose or 125 mcg (of the free cation)/dose. 
     
     
         28 . The method of  claim 26 , wherein said one or more dry powder compositions comprises a first and a second dry powder composition, each in unit dose form, wherein
 said first dry powder composition comprises said fluticasone furoate in an amount of about 100 mcg/dose; and;   said second dry powder composition comprises said umeclidinium bromide in an amount of about 62.5 mcg (of the free cation)/dose or 125 mcg (of the free cation)/dose.   
     
     
         29 . The method of  claim 28 , wherein
 said first dry powder composition comprises said fluticasone furoate and lactose monohydrate; and   said second dry powder composition comprises said umeclidinium bromide and further comprises lactose monohydrate, and magnesium stearate.   
     
     
         30 . The method of  claim 29 , wherein said magnesium stearate is present in an amount of 0.6% w/w of said second composition. 
     
     
         31 . The method of  claim 29 , wherein said first and second compositions in unit dose form are presented for simultaneous administration. 
     
     
         32 . The method of  claim 19 , wherein the inhaled pharmaceutical product further comprises vilanterol trifenatate. 
     
     
         33 . The method of  claim 32 , wherein the inhaled pharmaceutical product comprises a dry powder inhaler, said dry powder inhaler comprising one or more dry powder compositions. 
     
     
         34 . The method of  claim 33 , wherein said one or more dry powder compositions are present in unit-dose form. 
     
     
         35 . The method of  claim 34 , wherein said fluticasone furoate is present in an amount of about 100 mcg/dose and said vilanterol trifenatate is present in an amount of about 25 mcg (of the free base)/dose. 
     
     
         36 . The method of  claim 35 , wherein said dry powder inhaler comprises a first and a second dry powder composition,
 said first dry powder composition comprising said fluticasone furoate in an amount of about 100 mcg/dose, and;   said second dry powder composition comprising said vilanterol trifenatate in an amount of about 25 mcg (of the free base)/dose.   
     
     
         37 . The method of  claim 36 , wherein said first dry powder composition further comprises lactose monohydrate; and said second dry powder composition further comprises lactose monohydrate and magnesium stearate. 
     
     
         38 . The method of  claim 36 , wherein said magnesium stearate is present in an amount of 0.6% w/w of the second composition. 
     
     
         39 . The method of  claim 36 , wherein said first and second dry powder compositions are in unit dose form and are presented for simultaneous administration. 
     
     
         40 . The method of  claim 19 , wherein the inhaled pharmaceutical product further comprises umeclidinium bromide and vilanterol trifenatate. 
     
     
         41 . The method of  claim 40 , wherein the inhaled pharmaceutical product comprises a dry powder inhaler, wherein said dry powder inhaler comprising one or more dry powder compositions. 
     
     
         42 . The method of  claim 41 , wherein said one or more dry powder compositions are in unit-dose form. 
     
     
         43 . The method of  claim 42 , wherein said fluticasone furoate is present in an amount of about 100 mcg/dose, said umeclidinium bromide is in an amount of about 62.5 mcg (of the free cation)/dose or 125 mcg (of the free cation)/dose, and said vilanterol trifenatate is in an amount of about 25 mcg (of the free base)/dose. 
     
     
         44 . The method of  claim 43 , wherein the dry powder inhaler comprises a first and a second dry powder composition,
 said first dry powder composition comprising said fluticasone furoate in an amount of about 100 mcg/dose, and;   said second dry powder composition comprising said umeclidinium bromide in an amount of about 62.5 mcg (of the free cation)/dose or 125 mcg (of the free cation)/dose and said vilanterol trifenatate in an amount of about 25 mcg (of the free base)/dose.   
     
     
         45 . The method of  claim 44 , wherein said first dry powder composition further comprises lactose monohydrate; and said second dry powder composition further comprises lactose monohydrate and magnesium stearate. 
     
     
         46 . The method of  claim 45 , wherein said magnesium stearate is present in an amount of 0.6% w/w of the second composition. 
     
     
         47 . The method of  claim 45 , wherein said first and second dry powder compositions are in unit dose form and are presented for simultaneous administration.