Claims for Patent: 11,484,531
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Summary for Patent: 11,484,531
| Title: | 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 (FEV1); 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 FEV1 less than 50 percent using a nebulizer as the inhalation delivery device provides significantly greater improvements in trough FEV1 and trough forced vital capacity (FVC) compared to administration of a bronchodilator to such patients using a dry powder inhaler. |
| Inventor(s): | Christopher Noel Barnes, Glenn D. Crater, Edmund J. Moran, Srikanth Pendyala |
| Assignee: | Theravance Biopharma R&D IP LLC |
| Application Number: | US16/555,216 |
| Patent Claims: |
1. A method for treating chronic obstructive pulmonary disease in a patient, the method comprising: (a) selecting a patient having chronic obstructive pulmonary disease for treatment based on the patient having a peak inspiratory flow rate less than about 60 L/min and a percent predicted force expiratory volume in one second less than about 50 percent; and (b) administering a pharmaceutical composition comprising about 175 μg of revefenacin, or a pharmaceutically acceptable salt thereof, in 3 mL of an aqueous solution to the selected patient once daily using a nebulizer. 2. The method of claim 1, wherein the patient has a peak inspiratory flow rate less than about 50 L/min. 3. The method of claim 1, wherein the patient has a percent predicted force expiratory volume in one second less than about 40 percent. 4. 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 force expiratory volume in one second in the range of from about 20 percent to less than about 50 percent. 5. The method of any one of claims 1 to 4, wherein the pharmaceutical composition has a pH in the range of about 4.5 to about 5.5. 6. The method of any one of claims 1 to 4, wherein the pharmaceutical composition has a pH of about 4.8 to about 5.2. 7. The method of any one of claims 1 to 4, wherein the pharmaceutical composition is isotonic. 8. The method of any one of claims 1 to 4, wherein the pharmaceutical composition further comprises sodium chloride, citric acid and sodium citrate. 9. The method of any one of claims 1 to 4, wherein the pharmaceutical composition is sterile, isotonic and has a pH of about 4.8 to about 5.2. 10. The method of any one of claims 1 to 4, wherein the pharmaceutical composition is administered using a jet nebulizer. |
