DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF ASTHMA
The present invention refers to the treatment of asthma by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.
1 - 49 . (canceled)
50 . A method for the treatment of severe nocturnal asthma in a patient in need thereof, which comprises administering to said patient once daily an effective amount of prednisone contained in a delayed release dosage form, wherein said treatment is administered at least for 2 weeks.
51 . The method of claim 50 , wherein the asthma is reversible or non reversible upon bronchodilator administration.
52 . The method of claim 50 , wherein the asthma is uncontrolled.
53 . The method of claim 50 , wherein said patients are suffering from at least two nocturnal awakenings per week on average.
54 . The method of claim 50 , wherein said patients are suffering from at least three nocturnal awakenings per week on average.
55 . The method of claim 50 , wherein the treatment comprises administration of the delayed release dosage form for at least about four weeks.
56 . The method of claim 50 , wherein the treatment comprises administration of the delayed release dosage form for at least about 3 months.
57 . The method of claim 50 , wherein the treatment comprises administration of the delayed release dosage form for at least about 12 months.
58 . The method of claim 50 , wherein said patient is suffering from medium to low scoring of the Asthma Quality of Life Questionnaire (AQLQ).
59 . The method of claim 50 , wherein said patient is suffering from high to medium scoring of the Asthma Control Questionnaire (ACQ).
60 . The method of claim 50 , wherein said patient is suffering from frequent usage of emergency medication.
61 . The method of claim 50 , wherein said patient has not previously been treated with an oral immediate release glucocorticoid, inhaled glucocorticoids, short and long acting β 2 adrenergic receptor agonists, leukotriene antagonists, theophylline or combinations thereof.
62 . The method of claim 50 , wherein said patient has previously undergone treatment with inhaled glucocorticoids, short and long acting β 2 adrenergic receptor agonists, leukotriene antagonists, theophylline, or combinations thereof.
63 . The method of claim 50 , which further comprises administering to said patient an effective amount of inhaled glucocorticoids, short and long acting β 2 adrenergic receptor agonists, leukotriene antagonists, theophylline, or combinations thereof.
64 . The method of claim 50 , wherein said patient has previously undergone treatment with an oral immediate release dosage form of a glucocorticoid.
65 . The method of claim 50 , wherein said patient is refractory to said treatment with an oral immediate release dosage form of a glucocorticoid.
66 . The method of claim 50 , wherein the delayed release dosage form is administered in the evening.
67 . The method of claim 50 , wherein the delayed release dosage form is administered between about 9:00 pm and about 11:00 pm.
68 . The method of claim 50 , wherein the delayed release dosage form has an in vivo lag time (tlag) of from about 2 hours to about 6 hours after administration.
69 . The method of claim 50 , wherein the delayed release dosage form more specifically has an in vivo lag time (tlag) of from about 3 hours to about 5 hours after administration.
70 . The method of claim 50 , wherein the delayed release dosage form is administered with not later than 3 hours after the patient consumes a meal.
71 . The method of claim 50 , wherein the delayed release dosage form is a tablet or a capsule.
72 . The method of claim 50 , wherein the delayed release dosage form does not have an enteric coating and has a drug release behaviour which is independent of pH.
73 . The method of claim 50 , wherein the delayed release dosage form comprises a non-soluble/non-swellable coating and a core comprising the active agent and a disintegrant and/or a swelling agent.