Claims for Patent: 12,048,692
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Summary for Patent: 12,048,692
| 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: | Thera Vance Biopharma R&d Ip LLC |
| Application Number: | US18/137,919 |
| Patent Claims: |
1. A method for treating chronic obstructive pulmonary disease (COPD) in a patient with severe to very severe COPD, the method comprising: (a) selecting a patient having a percent predicted forced expiratory volume in one second less than 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. 2. The method of claim 1, wherein the low peak inspiratory flow rate is less than about 50 L/min. 3. The method of claim 1, wherein the patient has a percent predicted forced expiratory volume in one second less than about 40 percent. 4. The method of claim 1, wherein the patient has a percent predicted forced expiratory volume in one second less than about 30 percent. 5. The method of claim 1, wherein the patient has very severe COPD. 6. 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 a percent predicted forced expiratory volume in one second in the range of from about 20 percent to less than 50 percent. 7. The method of claim 1, wherein the pharmaceutical composition comprises about 175 μg/3 mL of revefenacin or a pharmaceutically acceptable salt thereof. 8. The method of claim 1, wherein the pharmaceutical composition has a pH in the range of about 4.5 to about 5.5. 9. The method of claim 1, wherein the pharmaceutical composition has a pH of about 4.8 to about 5.2. 10. The method of claim 1, wherein the pharmaceutical composition is isotonic. 11. The method of claim 1, wherein the pharmaceutical composition further comprises sodium chloride, citric acid and sodium citrate. 12. The method of claim 1, wherein the pharmaceutical composition is sterile, isotonic and has a pH of about 4.8 to about 5.2. 13. The method of claim 1, wherein the pharmaceutical composition is administered using a jet nebulizer. 14. The method of claim 1, wherein the pharmaceutical composition is administered once daily. |
