Medicinal treatment of chronic pulmonary inflammatory diseases with norketotifen

Abstract

The methods disclosed herein relate to the treatment of chronic pulmonary disorders, such as for example asthma, COPD, cough, bronchial hyperactivity and bronchitis, in human patients, by administering a therapeutically effective amount of RS-norketotifen.

1 - 25 . (canceled) 
     
     
         26 . A method of treating a chronic, inflammatory pulmonary condition in a human patient in need of such treatment, the method comprising orally administering to the human patient in need thereof a therapeutically effective amount of RS-norketotifen or a pharmaceutically acceptable salt thereof, wherein the human patient is susceptible to sedative side effects upon administration of Generation-1 antihistamines, wherein the therapeutically effective amount of RS-norketotifen does not produce sedative side effects upon administration to the human patient, and wherein the amount of said RS-norketotifen or a pharmaceutically acceptable salt thereof is 0.5 mg to 20 mg, expressed as free base, and is dosed once or multiple times daily in said method. 
     
     
         27 . The method of  claim 26 , wherein the pulmonary inflammatory disorder is selected from the group consisting of asthma, COPD, cough, bronchial hyperactivity, and bronchitis. 
     
     
         28 . The method of  claim 26 , further comprising pulmonary administration, sublingual administration, parenteral administration, dermal administration, transdermal administration, rectal administration, buccal administration, of a therapeutically effective dose of RS-norketotifen or a pharmaceutically acceptable salt thereof. 
     
     
         29 . The method of  claim 26 , the method further comprising co-administration of RS-norketotifen and a therapeutically effective amount of a bronchodilating adrenergic beta-receptor agonist, an insecticidal agent, an antibacterial agent, an antiviral agent, vitamin D, a vitamin D analog, a corticosteroid, a cyclooxygenase inhibitor, a leukotriene antagonist, a lipoxygenase inhibitor, a kinase inhibitor, or an immunosuppressant drug. 
     
     
         30 . The method of  claim 29 , wherein the bronchodilating adrenergic beta-receptor agonist is salbutamol, terbutaline, fenoterol, formoterol, salmeterol, or an optically or therapeutically active isomer thereof. 
     
     
         31 . The method of  claim 30 , wherein the bronchodilating adrenergic beta-receptor agonist is administered by inhalation, nasal, parenteral, topical, transdermal, rectal, sublingual or oral administration. 
     
     
         32 . A method of treating an atopic pulmonary inflammatory disorder in a human patient, comprising determining whether said patient is susceptible to adverse sedative effects of compounds with antihistaminic activity, and if said determination is positive, administering to said patient in need thereof an oral formulation comprising a therapeutically effective amount of RS-norketotifen or a pharmaceutically acceptable salt of RS-norketotifen.