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Claims for Patent: 5,889,015

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Claims for Patent: 5,889,015

Title: Use of mometasone furoate for treating lower airway passage and lung diseases
Abstract:The administration of aerosolize particles of mometasone furoate in the form of dry powders, solutions, or aqueous suspension for treating corticosteroid-responsive diseases of the surfaces of upper and/or lower airway passages and/or lungs, e.g., allergic rhinitis and asthma is disclosed.
Inventor(s): Sequeira; Joel A. (Scotch Plains, NJ), Cuss; Francis M. (Basking Ridge, NJ), Nolop; Keith B. (Millburn, NJ), Chaudry; Imtiaz A. (North Caldwell, NJ), Nagabhushan; Nagamani (Parsippany, NJ), Patrick; James E. (Belle Meade, NJ), Cayen; Mitchell (Bedminster, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:08/911,300
Patent Claims: 1. A method of treating a corticosteroid-responsive disease of the lower airway passages or of the lungs in patients afflicted with said disease, comprising the steps of:

administering to the surfaces of said lower airway passages or lungs of said patients a daily dose, administered at least once a day, of a substantially non-systematically bioavailable amount of aerosolized particles of mometasone furoate effective for treating said disease.

2. The method of claim 1 wherein the disease is asthma.

3. The method of claim 1 wherein the disease is an allergic or inflammatory disease of the lower airway passages and/or lungs.

4. A method of treating a corticosteroid-responsive disease of the lower airway passages in patients afflicted with said disease comprising the step of:

administering, on a schedule consisting of once-daily or twice-daily doses, to the surfaces of said lower airway passages of said patients a substantially non-systemically bioavailable amount of aerosolized particles of mometasone furoate effective for treating said disease.

5. The method of claim 4, wherein said substantially non-systemically bioavailable amount of aerosolized particles of mometasone furoate effective for treating said disease ranges from about 10 to about 2000 .mu.g per day.

6. The method of claim 4, wherein said mometasone furoate is administered by oral inhalation in one maintenance dose daily.

7. A method of treating a corticosteroid-responsive disease of the lower airway passages in patients afflicted with said disease comprising the steps of:

providing mometasone furoate particles in a device selected from the group consisting of a dry powder inhaler and a pressurized aerosol metered dose inhaler;

orally administering to said patient each day a substantially non-systemically bioavailable amount from about 10 to about 2000 .mu.g of aerosolized particles of mometasone furoate from said device to the surfaces of said lower airway passages of said patients in a once-daily initial or maintenance dose.

8. The method of claim 7, wherein said amount of aerosolized particles of mometasone furoate ranges from about 50 to about 1000 .mu.g.

9. A method of treating allergic and/or inflammatory diseases of the lower airway passages and/or lung in patients afflicted with at least one of said diseases which comprises administering once-a-day via oral inhalation to the surfaces of the lower airway passages of said patients an amount of mometasone furoate effective to maximize topically treating said allergic and/or inflammatory diseases in the lower airway passage and/or lungs while simultaneously substantially minimizing the systemic bioavailability thereof.

10. The method of claim 9 wherein the disease treated is an inflammatory disease.

11. The method of claim 9 wherein the inflammatory disease treated is a inflammatory disease associated with chronic obstruction pulmonary disease.

12. The method of claim 9 wherein the disease treated is a granulomtous disease of the lungs, and upper and lower airway passages.

13. The method of claim 9 wherein the disease treated is a non-malignant proliferative and/or inflammatory disease of the lungs.

14. The method of claim 13 wherein the non-malignant proliferative and/or inflammatory disease of the lungs is idiopathic pulmonary fibrosis.

15. The method of claim 9 wherein the diseased treated is bronchopulmonary dysphasia.

16. The method of claim 9 wherein the disease treated is hypersensitivity pneumonitis.

17. The method of claim 9 wherein the amount of mometasone furoate administered is in the range of about 10 to about 5000 micrograms/day.

18. A method of treating asthma in a patient afflicted with asthma which comprises administering once-a-day to the surfaces of the lower airway passages and lungs of the patient an amount of aerosolized particles of mometasone furoate effective to maximize treating asthma in the lower airway passages and lungs while simultaneously substantially minimizing systemic bioavailability thereof.

19. The method of claim 18 wherein the amount of mometasone furoate administered is in the range of about 50 to about 1000 micrograms/day.

20. The method of claim 18 wherein the mometasone furoate is administered by oral inhalation.

21. The method of claim 20 wherein a metered dose inhaler is used to administer the mometasone furoate in the amount of about 50 to about 1000 micrograms a day.

22. The method of claim 20 wherein a dry powder inhaler is used to administer the mometasone furoate In the amount of 100 to 600 micrograms a day.

23. The method of claim 19 wherein the mometasone furoate is intranasally administered.

24. The method of claim 23 wherein the mometasone furoate is administered intranasally in the form of an aqueous suspension.

25. A method of producing a rapid onset of action in treating asthma in patients afflicted with asthma which comprises administering via oral inhalation to the lower airway passages and lungs of said patients a non-systematically bioavailable amount of aerosolized particles of mometsone furoate effective for producing said accelerated onset of action.

26. The method of claim 25 wherein a metered dose inhaler is used to administer the mometasone furoate in the dosage range of 50 to 1000 mcg/day.

27. The method of claim 25 wherein a dry powder inhaler is used to administer the mometasone furoate.

28. The method of claim 25 wherein the mometasone furoate is administered in a range of about 100 to 600 mcg/day.

29. The method of claim 25 wherein the mometasone furoate is administered in admixture with lactose.

30. A method of treating a corticosteroid-responsive disease of the lower airway passages in patients afflicted with said disease comprising the step of:

administering in once-daily initial or maintenance doses to the surfaces of said lower airway passages of said patients a substantially non-systemically bioavailable amount of aerosolized particles of mometasone furoate, effective for treating said disease.

31. A method of treating a corticosteroid-responsive disease of the lower airway passages in patients afflicted with said disease comprising the steps of:

providing mometasone furoate particles in a device selected from the group consisting of a dry powder inhaler and a pressurized aerosol metered dose inhaler;

administering by oral inhalation a substantially non-systemically bioavailable amount totaling from about 10 to about 2000 .mu.g per day of aerosolized particles of mometasone furoate from said device to the surfaces of said lower airway passages of said patients, in from one to four doses daily.

32. The method of claim 31, wherein said daily amount of aerosolized particles of mometasone furoate totals from about 50 to about 1000 .mu.g.

33. The method of claim 31, wherein said aerosolized particles of mometasone furoate are administered in one or two daily doses.

34. The method of claim 31, wherein said aerosolized particles of mometasone furoate are administered in one daily dose.

35. The method of claim 31, wherein said daily amount of aerosolized particles of mometasone furoate totals from about 25 to about 400 .mu.g.
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