Method and system for the treatment of chronic copd with nebulized anticholinergic administrations

Abstract

A method is provided for improving lung function in COPD by administering a muscarinic antagonist with a high efficiency nebulizer.

1 - 38 . (canceled) 
     
     
         39 . A composition for administration with a high efficiency nebulizer, comprising a concentrated, preservative-free, pH-adjusted solution formulation of a muscarinic antagonist. 
     
     
         40 . The composition of  claim 39 , wherein the composition is an aqueous solution of glycopyrrolate having a volume of about 0.5 mL to about 1.5 mL, a glycopyrrolate concentration of about 25 μg/mL to about 250 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents. 
     
     
         41 . The composition of  claim 40 , wherein the glycopyrrolate concentration is about 25 μg/mL and/or the volume is about 1 mL and/or the pH is about 3 to about 5. 
     
     
         42 . A method of treating a respiratory condition in a subject comprising administering to the subject a composition of  claim 39 . 
     
     
         43 . The method of  claim 42 , wherein the respiratory condition is chronic bronchitis, chronic obstructive pulmonary disease (COPD), or emphysema. 
     
     
         44 . A method of treating a respiratory condition in a subject comprising administering to the subject a composition of  claim 40 . 
     
     
         45 . The method of  claim 44 , wherein the glycopyrrolate concentration is about 25 μg/mL and/or the volume is about 1 mL and/or the pH is about 3 to about 5. 
     
     
         46 . The method of  claim 44 , wherein the composition comprises an aqueous solution of glycopyrrolate having a volume of about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 
     
     
         47 . The method of  claim 46 , wherein said aqueous solution further comprises citric acid or a pharmaceutically acceptable salt thereof. 
     
     
         48 . The method of  claim 44 , wherein the respiratory condition is chronic bronchitis or emphysema. 
     
     
         49 . The method of  claim 48 , wherein the glycopyrrolate concentration is about 25 μg/mL and/or the volume is about 1 mL and/or the pH is about 3 to about 5. 
     
     
         50 . The method of  claim 48 , wherein the composition comprises an aqueous solution of glycopyrrolate having a volume of about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 
     
     
         51 . The method of  claim 50 , wherein the aqueous solution further comprises citric acid or a pharmaceutically acceptable salt thereof. 
     
     
         52 . A method of treating a patient having chronic obstructive pulmonary disease (COPD), comprising administering to the patient, with a high efficiency nebulizer, a nominal dose of a composition comprising a muscarinic antagonist that provides the patient with a therapeutic effect at least about 24 hours after administering the muscarinic antagonist to the patient. 
     
     
         53 . The method of  claim 52 , wherein the muscarinic antagonist is glycopyrrolate. 
     
     
         54 . The method of  claim 53 , wherein the glycopyrrolate concentration is about 25 μg/mL and/or the volume of the composition is about 1 mL and/or the pH of the composition is about 3 to about 5. 
     
     
         55 . The method of  claim 52 , wherein the composition comprises an aqueous solution of glycopyrrolate having a volume of about 1.0 mL, a glycopyrrolate concentration of about 25 μg/mL, and a pH of about 3 to about 5, wherein the solution is free of other bronchodilating agents and is substantially free of preservatives. 
     
     
         56 . The method of  claim 55 , wherein said aqueous solution further comprises citric acid or a pharmaceutically acceptable salt thereof. 
     
     
         57 . A method for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) in a patient, the method comprising:
 (a) administering to the patient, with a high efficiency nebulizer, a first nominal dose of a first aqueous inhalation solution comprising less than about 80 μg of glycopyrrolate, and free of other bronchodilating agents; and   (b) administering to the patient, with a high efficiency nebulizer, a second nominal dose of a second aqueous inhalation solution comprising less than about 80 μg of glycopyrrolate, and free of other bronchodilating agents;   
       wherein the combination of the first and second nominal doses provides the patient with a therapeutic effect at least 24 hours after administering the first nominal dose to the patient; and 
       wherein the first and second nominal doses are administered to the patient in a 24-hour period. 
     
     
         58 . The method of  claim 57 , wherein the glycopyrrolate concentration is about 25 μg/mL.