Use of ciclesonide for the treatment of respiratory diseases

Abstract

Disclosed herein are novel methods of treating respiratory diseases, and in particular the treatment of asthmatic children.

1 . Method for treating or preventing a respiratory disease in a patient, which patient is a child and the method comprising administering to the patient a dose of a composition containing ciclesonide, a pharmaceutically acceptable salt, solvates or physiologically functional derivative thereof, wherein the dose of the composition comprises ciclesonide in an amount of from 20 to 200 μg. 
     
     
         2 . Method according to  claim 1 , wherein the dose comprises 20, 40, 60, 80, 100, 120, 140, 160, 180 or 200 μg ciclesonide. 
     
     
         3 . Method according to  claim 1 , wherein the dose comprises 40, 80 or 160 μg ciclesonide. 
     
     
         4 . Method according to  claim 1 , wherein the child is a pre-pubertal human. 
     
     
         5 . Method according to  claim 1 , wherein the child is a human from 8 to 12 years of age. 
     
     
         6 . Method according to  claim 1 , wherein the dose is a daily dose in a continuous treatment regimen. 
     
     
         7 . Method according to  claim 6 , wherein the treatment period is more than one day. 
     
     
         8 . Method according to  claim 7 , wherein the treatment period is more than one week. 
     
     
         9 . Method according to  claim 1 , which has no effect on growth rate of the patient. 
     
     
         10 . Method according to  claim 1 , wherein the composition comprises a pharmaceutically acceptable carrier and/or one or more excipients. 
     
     
         11 . Method according to  claim 1  wherein ciclesonide is selected from the group of [11β,16α(R)]-16,17-[(Cyclohexylmethylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)pregna-1,4-dien-3,20-dion, [11β,16α(S)]-16,17-[(Cyclohexylmethylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-dien3,20-dion, [11β,16α(R,S)]-16,17-[(Cyclohexyl-methylen)bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxoprop-oxy)pregna-1,4-dien3,20-dion, 16α,17-(22R)-Cyclohexylmethyl-endioxy-11β,21-dihydroxypregna-1,4-dien-3,20-dion, 16α,17-(22S)-Cyclohexylmethylendioxy-11β,21-dihydroxypregna-1,4-dien-3,20-dion and 16α,17-(22R,S)-Cyclohexylmethylendioxy-11β,21-dihydroxypregna-1,4-dien-3,20-dion. 
     
     
         12 . Method according to  claim 1 , comprising a once daily dosage regimen. 
     
     
         13 . Method according to claim, wherein the composition is suitable for administration by inhalation. 
     
     
         14 . Method according to  claim 13  wherein the composition is a pharmaceutical aerosol formulation comprising a therapeutically effective amount of ciclesonide and a hydrofluorocarbon propellant, preferably selected from 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and a mixture thereof, and cosolvent in an amount effective to solubilize ciclesonide and optionally a surfactant. 
     
     
         15 . Method according to  claim 14 , wherein the cosolvent is ethanol. 
     
     
         16 . Method according to  claim 13  wherein the composition is a pharmaceutical aerosol formulation comprising particles of ciclesonide in a therapeutically effective amount and a hydrofluorocarbon propellant, preferably selected from 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and a mixture thereof, and 0.01 to 5% w/w based upon propellant of polar cosolvent and optionally a surfactant. 
     
     
         17 . Method according to  claim 13  wherein the composition is a dry powder and the carrier is a saccharide 
     
     
         18 . Method according to  claim 13  wherein the carrier is lactose monohydrate. 
     
     
         19 . Method according to  claim 1 , wherein the clinical condition is selected from the group of asthma, nocturnal asthma, exercise-induced asthma, chronic obstructive pulmonary diseases (COPD), chronic and wheezy bronchitis, emphysema, respiratory tract infection and upper respiratory tract disease, rhinitis, allergic and seasonal rhinitis. 
     
     
         20 . Method according to  claim 1 , wherein the clinical condition is mild or moderate asthma. 
     
     
         21 . Method according to  claim 1 , wherein the ciclesonide essentially consists of R epimer.