Method for treating respiratory diseases

• US 6,598,603 B1
• Filed: 12/23/1998
• Issued: 07/29/2003
• Est. Priority Date: 12/31/1997
• Status: Expired due to Term

• Current Assignee: Astrazeneca AB (Astrazeneca PLC)
• Original Assignee: Astra AB (Astrazeneca PLC)
• Inventors: Eriksson, Göran, Andersson, Bertil, Conradsson, Thor-Björn
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/220,137
• Time in Patent Office: 1,679 Days
• Field of Search: 128/200.14, 128/200.23, 128/203.12, 128/203.15
• US Class Current: 128/200.24
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics

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.

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.