Methods for treating chronic obstructive pulmonary disease

Abstract

Methods for treating chronic obstructive pulmonary disease (COPD) in a patient are disclosed. In the methods, a patient having COPD is selected for treatment based on the patient's peak inspiratory flow rate (PIFR) and percent predicted force expiratory volume in one second (FEV 1 ); and a bronchodilator is administered to the selected patient using a nebulizer. Administration of a bronchodilator to patients having low PIFR and a percent predicted FEV 1 less than 50 percent using a nebulizer as the inhalation delivery device provides significantly greater improvements in trough FEV 1 and trough forced vital capacity (FVC) compared to administration of a bronchodilator to such patients using a dry powder inhaler.

1 - 53 . (canceled) 
     
     
         54 . A method for treating chronic obstructive pulmonary disease (COPD) in a patient with moderate to very severe COPD, the method comprising:
 (a) selecting a patient having a percent predicted forced expiratory volume in one second less than about 50 percent; and   (b) administering a pharmaceutical composition comprising an aqueous solution of revefenacin or a pharmaceutically acceptable salt thereof to the selected patient using a nebulizer;   wherein the patient has a low peak inspiratory flow rate.   
     
     
         55 . The method of  claim 54 , wherein the low peak inspiratory flow rate is less than about 60 L/min. 
     
     
         56 . The method of  claim 54 , wherein the low peak inspiratory flow rate is less than about 50 L/min. 
     
     
         57 . The method of  claim 54 , wherein the patient has a percent predicted forced expiratory volume in one second less than about 40 percent. 
     
     
         58 . The method of  claim 54 , wherein the patient has a percent predicted forced expiratory volume in one second less than about 30 percent. 
     
     
         59 . The method of  claim 54 , wherein the patient has severe to very severe COPD. 
     
     
         60 . The method of  claim 54 , wherein the patient has a peak inspiratory flow rate in the range of about 20 L/min to less than about 60 L/min and a percent predicted forced expiratory volume in one second in the range of from about 20 percent to less than about 50 percent. 
     
     
         61 . The method of  claim 54 , wherein the pharmaceutical composition comprises about 175 μg/3 mL of revefenacin or a pharmaceutically acceptable salt thereof. 
     
     
         62 . The method of  claim 54 , wherein the pharmaceutical composition has a pH in the range of about 4.5 to about 5.5. 
     
     
         63 . The method of  claim 54 , wherein the pharmaceutical composition has a pH of about 4.8 to about 5.2. 
     
     
         64 . The method of  claim 54 , wherein the pharmaceutical composition is isotonic. 
     
     
         65 . The method of  claim 54 , wherein the pharmaceutical composition further comprises sodium chloride, citric acid and sodium citrate. 
     
     
         66 . The method of  claim 54 , wherein the pharmaceutical composition is sterile, isotonic and has a pH of about 4.8 to about 5.2. 
     
     
         67 . The method of  claim 54 , wherein the pharmaceutical composition is administered using a jet nebulizer. 
     
     
         68 . The method of  claim 54 , wherein the pharmaceutical composition is administered once daily.