Dosage regimen for the treatment of acute exacerbations of inflammatory conditions
This invention relates to a novel dosage regimen for administration of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable derivative thereof, namely in the treatment of acute exacerbations of inflammatory conditions.
1. A method for the treatment of acute exacerbations of an inflammatory respiratory disease in a human patient suffering from an inflammatory respiratory disease where the acute exacerbation is affecting the respiratory tract, comprising administering to a human patient in need thereof three to five separate therapeutically effective doses of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof over a minimum period of five days and a maximum period of ten days, with at least one day between every dose.
2. A method of alleviating a symptom of an acute exacerbation of an inflammatory respiratory disease in a human patient suffering from an inflammatory respiratory disease where the acute exacerbation is affecting the respiratory tract, comprising administering to a human patient in need thereof three to five separate therapeutically effective doses of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof over a minimum period of five days and a maximum period of ten days, with at least one day between every dose.
3. A method of increasing the tolerability of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof in a human patient suffering from an inflammatory respiratory disease, which comprises administering to a human patient in need thereof, and where said patient is suffering an acute exacerbation affecting the respiratory tract, three to five separate doses of a pharmaceutical composition comprising 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof, over a minimum period of five days and a maximum period of ten days, with at least one day between every dose administration.
4. The method of claim 1 , wherein three separate doses are given over a minimum period of five days and a maximum period of seven days, with at least one day between every dose administration.
5. The method of claim 1 , wherein four separate doses are given over a minimum period of seven days and a maximum period of ten days, with at least one day between every dose administration.
6. The method of claim 1 , wherein five separate doses are given over a period ten days, with at least one day between every dose administration.
7. The method of claim 1 , wherein said inflammatory respiratory disease is selected from the group consisting of asthma, COPD, cystic fibrosis, and adult respiratory distress syndrome.
8. The method of claim 7 , wherein the acute exacerbation of an inflammatory respiratory disease is an acute exacerbation of asthma.
9. The method of claim 1 , wherein the amount of the dose of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof is reduced over the course of at least the first three separate administrations.
10. The method of claim 1 , wherein the initial dose of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable salt, hydrate, or solvate thereof is at least 20% greater than any of the subsequent doses.
11. The method of claim 9 , wherein the third dose is a smaller dose than the second dose.
12. The method of claim 1 , wherein the dose is administered on days 1, 6 and 10, and the dose is 25 mg or 75 mg.
13. The method of claim 1 , wherein said patient is administered no more than three separate therapeutically effective doses of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide, wherein the effective dose is 75 mg, and wherein the doses are administered on days 1, 6 and 10.
14. The method of claim 1 wherein said patient is administered not more than three separate therapeutically effective doses of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide, wherein the effective dose is 25 mg, and wherein the doses are administered on days 1, 6 and 10.
15. The method of claim 13 , wherein the acute exacerbation of an inflammatory respiratory disease is an acute exacerbation of asthma.
16. The method of claim 14 , wherein the acute exacerbation of an inflammatory respiratory disease is an acute exacerbation of asthma.