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Claims for Patent: 6,598,603

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Claims for Patent: 6,598,603

Title: Method for treating respiratory diseases
Abstract:The invention provides a novel method of treating respiratory diseases, e.g., pediatric asthma, in a continuing regimen with not more than one daily dose of the drug budesonide using a nebulizer.
Inventor(s): Andersson; Bertil (Bjarred, SE), Conradsson; Thor-Bjorn (Sodra Sandby, SE), Eriksson; Goran (Dalby, SE)
Assignee: Astra Aktiebolag (SE)
Application Number:09/220,137
Patent Claims: 1. A method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day.

2. The method of claim 1, wherein the frequency is once and only once per day.

3. The method of claim 2, wherein budesonide is the only active ingredient in the budesonide composition.

4. The method of claim 1, wherein the frequency is once and only once every other day.

5. The method of claim 4, wherein budesonide is the only active ingredient in the budesonide composition.

6. The method of claim 1, wherein the respiratory disease is selected from the group consisting of an inflammatory airway disease, croup, and bronchopulmonary dysplasia.

7. The method of claim 6, wherein the respiratory disease is asthma.

8. The method of claim 7, wherein budesonide is the only active ingredient in the budesonide composition.

9. The method of claim 6, wherein the respiratory disease is chronic obstructive pulmonary disease or bronchiolitis.

10. The method of claim 9, wherein budesonide is the only active ingredient in the budesonide composition.

11. The method of claim 6, wherein budesonide is the only active ingredient in the budesonide composition.

12. The method of claim 1, wherein the patient is one day to fifteen years old.

13. The method of claim 12, wherein budesonide is the only active ingredient in the budesonide composition.

14. The method of claim 1, wherein the patient is one month to eight years old.

15. The method of claim 14, wherein budesonide is the only active ingredient in the budesonide composition.

16. The method of claim 1, wherein the patient is six months to five years old.

17. The method of claim 16, wherein budesonide is the only active ingredient in the budesonide composition.

18. The method of claim 1, wherein the budesonide composition contains 0.05 mg to 15 mg budesonide.

19. The method of claim 18, wherein the budesonide composition further comprises water and 0.05 mg to 0.15 mg sodium edetate, 8.0 mg to 9.0 mg sodium chloride, 0.15 mg to 0.25 mg polysorbate, 0.25 mg to 0.30 mg anhydrous citric acid, and 0.45 mg to 0.55 mg sodium citrate per 1 ml of water.

20. The method of claim 19, wherein budesonide is the only active ingredient in the budesonide composition.

21. The method of claim 18, wherein budesonide is the only active ingredient in the budesonide composition.

22. The method of claim 1, wherein the budesonide composition contains 0.1 mg to 2.0 mg budesonide.

23. The method of claim 22, wherein budesonide is the only active ingredient in the budesonide composition.

24. The method of claim 1, wherein the budesonide composition contains 0.25 mg to 1.0 mg budesonide.

25. The method of claim 24, wherein budesonide is the only active ingredient in the budesonide composition.

26. The method of claim 1, wherein the budesonide composition is a suspension.

27. The method of claim 26, wherein budesonide is the only active ingredient in the budesonide composition.

28. The method of claim 1, wherein budesonide is the only active ingredient in the budesonide composition.

29. A kit for treating respiratory diseases, the kit comprising (a) a budesonide composition in a sealed container, the composition containing 0.05 mg to 15 mg budesonide and a solvent, and (b) a label indicating administration by nebulization in a continuing regimen at a frequency of not more than once per day.

30. The kit of claim 29, wherein budesonide is the sole active ingredient in the composition.
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