METHODS FOR TREATING CHRONIC OBSTRUCTIVE PULMONARY DISEASE
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.