Use of Ciclesonide for the Treatment of Respiratory Disease in a Smoking Patient

• US 20070134165A1
• Filed: 04/19/2005
• Published: 06/14/2007
• Est. Priority Date: 04/20/2004
• Status: Abandoned Application

• Current Assignee: Covis Pharma B.V. (Apollo Global Management, Inc.)
• Original Assignee: Altana Pharma AG (Takeda Pharmaceutical Company Limited)
• Inventors: Wurst, Wilhelm, Engelstaetter, Renate, Bethke, Thomas
• Application Number:
  US11/578,294
• Publication Number:
  US 20070134165A1
• Time in Patent Office: Days
• US Class Current: 424/45
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• 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 11/04 for throat disorders
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 11/16 Central respiratory analeptics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The invention relates to a new method of treatment of respiratory diseases, in particular the treatment of asthmatic smoking patients. The method comprises the administration of a pharmaceutical composition comprising ciclesonide.

Claims

1. A method for treating a respiratory disease in a patient, wherein said patient is a smoking patient, comprising administering to the patient a therapeutically effective and pharmacologically tolerable dose of a composition containing ciclesonide, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof.

2. The method according to claim 1, wherein the dose comprises 20, 40, 60, 80, 100, 120, 140, 160, 180, 200 or 320 μ

g ciclesonide.

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

4. The method according to claim 3, wherein the treatment period is more than one day.

5. The method according to claim 4, wherein the treatment period is more than one week.

6. The method according to claim 5, wherein the composition comprises a pharmaceutically acceptable carrier and/or one or more excipients.

7. The method according to claim 1, wherein ciclesonide is selected from the group consisting of [11β

,16α

(R)]-16,17-[(Cyclohexylmethylene)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-diene-3,20-dione, [11β

,16α

(S)]-16,17-[(Cyclohexylmethylene)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-diene3,20-dione, [11β

,16α

(R,S)]-16,17-[(Cyclohexylmethylene)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-diene3,20-dione, 16α

,17-(22R)-Cyclohexylmethylendioxy-11β

,21-dihydroxy-pregna-1,4-dien-3,20-dion, 16α

,17-(22S)-Cyclohexylmethylendioxy-11β

,21-dihydroxy-pregna-1,4-dien-3,20-dion and 16α

,17-(22R,S)-Cyclohexylmethylendioxy-11β

,21-dihydroxy-pregna-1,4-dien-3,20-dion.

8. The method according to claim 1, comprising a once daily dosage regimen.

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

10. The method according to claim 9, wherein the composition comprises ciclesonide dissolved in a pharmaceutically acceptable carrier.

11. The method according to claim 10, 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.

12. The method according to claim 11, wherein the cosolvent is ethanol.

13. The method according to claim 12, 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.

14. The method according to claim 9, wherein the composition is a dry powder and the carrier is a saccharide.

15. The method according to claim 14, wherein the carrier is lactose monohydrate.

16. The method according to claim 15, 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, allergic rhinitis and seasonal rhinitis.

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

18. The method according to claim 1, wherein the ciclesonide consists essentially of R epimer.

19. The method according to claim 1, wherein the patient has a smoking history of less than 10 pack per year of cigarettes or less than two pipe packs per year.

20. The method according to claim 19, wherein the patient has a smoking history of less than 10 pack per year of cigarettes or less than two pipe packs per year and has at least three months of smoking abstinence.

21. The method of claim 11, 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 a mixture thereof.

22. The method of claim 13, 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 a mixture thereof.