Granted Patent
B2
US 12,285,417 · App. 18/137,922 · Granted Apr 29, 2025
Methods for treating chronic obstructive pulmonary disease
Inventors:
Christopher Noel Barnes (South San Francisco, CA); Glenn D. Crater (South San Francisco, CA); Edmund J. Moran (South San Francisco, CA); Srikanth Pendyala (South San Francisco, CA)
Assignee:
THERA VANCE BIOPHARMA R&D IP, LLC
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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.
Claims (20)
1. A method for treating chronic obstructive pulmonary disease (COPD) in a patient having severe to very severe COPD, the method comprising:
selecting a patient having a percent predicted force expiratory volume in one second of less than about 50 percent; and
selecting a nebulizer as an inhalation delivery device to administer revefenacin, or a pharmaceutically acceptable salt thereof, to the patient,
wherein the patient has a peak inspiratory flow rate of less than about 60 L/min; and
wherein the method comprises administering a pharmaceutical composition comprising an aqueous solution of revefenacin, or a pharmaceutically acceptable salt thereof, to the patient using the nebulizer.
2. The method of claim 1 , wherein the patient has very severe COPD.
3. The method of claim 1 , wherein the patient has severe COPD.
4. The method of claim 1 , wherein the patient has a peak inspiratory flow rate of less than about 50 L/min.
5. The method of claim 1 , wherein the patient has a peak inspiratory flow rate of less than about 40 L/min.
6. The method of claim 1 , wherein the patient has a peak inspiratory flow rate of less than about 30 L/min.
7. The method of claim 1 , wherein the patient has a percent predicted forced expiratory volume in one second less than about 40 percent.
8. The method of claim 1 , wherein the patient has a percent predicted forced expiratory volume in one second less than about 30 percent.
9. The method of claim 1 , 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 50 percent.
10. The method of claim 1 , wherein the pharmaceutical composition comprises about 175 μg/3 mL of revefenacin or a pharmaceutically acceptable salt thereof.
11. The method of claim 1 , wherein the pharmaceutical composition has a pH in the range of about 4.5 to about 5.5.
12. The method of claim 1 , wherein the pharmaceutical composition has a pH of about 4.8 to about 5.2.
13. The method of claim 1 , wherein the pharmaceutical composition is isotonic.
14. The method of claim 1 , wherein the pharmaceutical composition further comprises sodium chloride, citric acid and sodium citrate.
15. The method of claim 1 , wherein the pharmaceutical composition is sterile, isotonic and has a pH of about 4.8 to about 5.2.
16. The method of claim 1 , wherein the pharmaceutical composition is administered using a jet nebulizer.
Assignments (1)
SECURITY INTEREST
Recorded Sep 24, 2026
From: THERAVANCE BIOPHARMA R&D IP, LLC
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 076134/0790 →
Continuity (4)
Provisional Application
62724805
· Aug 30, 2018
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