Use of ciclesonide for the treatment of respiratory diseases

• US 8,371,292 B2
• Filed: 09/15/2004
• Issued: 02/12/2013
• Est. Priority Date: 09/16/2003
• Status: Active Grant

• Current Assignee: Covis Pharma GmbH (Apollo Global Management, Inc.)
• Original Assignee: Nycomed GmbH (Takeda Pharmaceutical Company Limited)
• Inventors: Engelstaetter, Renate, Wurst, Wilhelm, Bethke, Thomas
• Primary Examiner(s): Soroush, Ali
• Application Number:
  US10/571,311
• Publication Number:
  US 20070025923A1
• Time in Patent Office: 3,072 Days
• Field of Search: 128/200.24, 514/1.7, 540/63
• US Class Current: 128/200.24
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The invention relates to new method of treatment of respiratory diseases, in particular the treatment of asthmatic children.

Claims

1. A method for treating a respiratory disease in a child while reducing or avoiding systemic side effects on said child'"'"'s growth rate, comprising administering to the child a dose of a composition containing ciclesonide as the sole active ingredient, or a pharmaceutically acceptable salt thereof, wherein the dose of the composition comprises ciclesonide in an amount of from 20 to 200 μ

g, and wherein ciclesonide consists essentially of its R-epimer.

2. The method according to claim 1, wherein the dose comprises 20, 40, 60, 80, 100, 120, 140, 160, 180 or 200 μ

g of ciclesonide.

3. The method according to claim 1, wherein the dose comprises 40, 80 or 160 μ

g of ciclesonide.

4. The method according to claim 1, wherein the child is a pre-pubertal human.

5. The method according to claim 1, wherein the child is a human from 6 to 12 years of age.

6. The method according to claim 1, wherein the dose is a daily dose in a continuous treatment regimen.

7. The method according to claim 6, wherein the treatment period is more than one day.

8. The method according to claim 7, wherein the treatment period is more than one week.

9. The method according to claim 1, wherein the composition comprises a pharmaceutically acceptable carrier and/or one or more excipients.

10. The method according to claim 1, wherein the dose is administered once daily.

11. The method according to claim 1, wherein the composition is suitable for administration by inhalation.

12. The method according to claim 11 wherein the composition is a pharmaceutical aerosol formulation comprising a therapeutically effective amount of ciclesonide and a hydrofluorocarbon propellant and cosolvent in an amount effective to solubilize ciclesonide and optionally a surfactant.

13. The method according to claim 12, wherein the cosolvent is ethanol.

14. The method according to claim 11 wherein the composition is a pharmaceutical aerosol formulation comprising particles of ciclesonide in a therapeutically effective amount and a hydrofluorocarbon propellant and 0.01 to 5% w/w based upon propellant of polar cosolvent and optionally a surfactant.

15. The method according to claim 11 wherein the composition is a dry powder and the carrier is a saccharide.

16. The method according to claim 11 wherein the carrier is lactose monohydrate.

17. The method according to claim 1, wherein the respiratory disease is selected from the group consisting of asthma, nocturnal asthma, exercise-induced asthma, chronic obstructive pulmonary diseases (COPD), chronic bronchitis, wheezy bronchitis, emphysema, respiratory tract infection, upper respiratory tract disease, rhinitis, and allergic and seasonal rhinitis.

18. The method according to claim 1, wherein the respiratory disease is mild or moderate asthma.

19. The method according to claim 12 wherein the hydrofluorocarbon propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and mixtures thereof.

20. The method according to claim 14 wherein the hydrofluorocarbon propellant is selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and mixtures thereof.

21. The method according to claim 1, wherein the composition is an intranasal spray or nasal drops.

22. The method according to claim 21, wherein the composition is an aqueous formulation for application to mucosa.

23. The method according to claim 21, wherein the composition is a non-aqueous formulation for application to mucosa.

24. The method according to claim 1, wherein the child is a human below the age of eighteen years.

25. The method according to claim 1, wherein the respiratory disease is rhinitis.

26. The method according to claim 1, wherein the respiratory disease is allergic rhinitis.

27. The method according to claim 1, wherein the respiratory disease is seasonal allergic rhinitis.

28. The method according to claim 1, wherein the amount of ciclesonide administered is a daily dose.

29. The method according to claim 2, wherein the amount of ciclesonide administered is a daily dose.

30. The method according to claim 3, wherein the amount of ciclesonide administered is a daily dose.

31. The method according to claim 1, wherein the dose is administered twice daily.

32. The method according to claim 11, 12, 13 or 14, wherein the composition is suitable for oral administration.

33. The method according to claim 11, 12, 13 or 14, wherein the composition is suitable for intranasal administration.

34. The method according to claim 26, wherein the composition is an aqueous intranasal spray, wherein the dose of the composition is administered once daily and comprises ciclesonide in an amount of 200 μ

g.

35. The method according to claim 13, wherein the respiratory disease is asthma, and wherein the dose of the composition is administered orally twice daily and comprises ciclesonide in an amount of 80 μ

g or 160 μ

g.