ACTH FOR TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME
Provided herein are methods of treatment of acute respiratory distress syndrome comprising administration of adrenocorticotropic hormone (ACTH), or fragment, analog, complex or aggregate thereof, or any combination thereof, to an individual in need thereof.
1 . A method of treating an individual diagnosed with, suspected of having, or preventing in an individual at risk for developing, acute respiratory distress syndrome (ARDS) comprising administration of a therapeutically effective amount of an adrenocorticotropic hormone (ACTH) peptide to an individual in need thereof, wherein the ACTH peptide is one or more of a peptide having a sequence with at least 90% homology to SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, or SEQ ID NO: 9.
2 . The method of claim 1 , wherein the ACTH peptide is administered in an initial phase of from one to five doses at daily intervals and a subsequent phase of one or more doses administered at intervals greater than one day.
3 . The method of claim 2 , wherein each of the one to five doses of the initial phase is between about 10 U and about 100 U.
4 . The method of claim 2 , wherein each of the one or more doses of the subsequent phase is between about 30 U and about 100 U.
5 . The method of claim 2 , wherein each of the one to five doses of the initial phase is between about 30 U and about 100 U, and each of the one or more doses of the subsequent phase is between about 20% and about 100% of each of the one to five doses of the initial phase.
6 . The method of claim 2 , wherein each of the one to five doses of the initial phase is between about 45 U and about 100 U, and each of the one or more doses of the subsequent phase is between about 10 U and about 80 U.
7 . The method of claim 2 , wherein each of the one to five doses of the initial phase is between about 60 U and about 100 U, and each of the one or more doses of the subsequent phase is between about 20 U and about 60 U.
8 . The method of claim 2 wherein each of the one to five doses of the initial phase is about 64 U, and each of the one or more doses of the subsequent phase is about 32 U.
9 . The method of claim 8 , wherein the one or more doses of the subsequent phase are administered at intervals selected from the group consisting of every other day, every two days, every three days, every four days, every 5 days, every 6 days, once a week, and every two weeks.
10 . The method of claim 1 , wherein the ACTH peptide is formulated as an injectable solution, immediate release formulation, prolonged release formulation, controlled release formulation, delayed release formulation, pulsatile release formulation, multiparticulate formulation or mixed immediate and controlled release formulation.
11 . The method of claim 1 , wherein the ACTH peptide is formulated as a gel.
12 . The method of claim 10 , wherein the ACTH peptide is administered intramuscularly, subcutaneously, intravenously, systemically, transmucosally, parenterally, intranasally, buccally, transdermally, rectally, by inhalation or by implant.
13 . The method of claim 12 , wherein the ACTH peptide is administered by injection intramuscularly or subcutaneously.
14 . The method of claim 1 , wherein the ACTH peptide is a recombinant ACTH peptide.
15 . The method of claim 1 , wherein the ACTH peptide is a porcine-derived ACTH peptide.
16 . The method of claim 1 , wherein the ACTH peptide is a synthetic ACTH peptide.
17 . The method of claim 1 , further comprising administration of a second therapeutic treatment, wherein the second therapeutic treatment is administered sequentially or simultaneously.
18 . The method of claim 17 , wherein the second therapeutic treatment is ventilation, a glucocorticoid, a surfactant, inhaled nitric oxide, an antioxidant, a protease inhibitor, a recombinant human activated protein C, a β2-agonist, lisofylline, a statin, inhaled heparin, a diuretic, a sedative, an analgesic, a muscle relaxant, an antibiotic, inhaled prostacyclin, inhaled synthetic prostacydin analog, ketoconazole, alprostadil, keratinocyte growth factor, beta-agonists, human monoclonal antibody (mAb) against tissue factor VIIa (TS factor 7a), interferon receptor agonists, insulin, perfluorocarbon, budesonide, recombinant human angiotensin-converting enzyme (ACE), recombinant human Clara cell 10 kDa (CC10) protein, tissue plasminogen activator, human mesenchymal stem cells, or nutritional therapy.
19 . The method of claim 17 , wherein the second therapeutic treatment is methylprednisolone, dexamethasone, prednisone, prednisolone, betamethasone, triamcinolone, triamcinolone acetonide, beclometasone, albuterol, lisofylline, rosuvastatin, inhaled heparin, inhaled nitric oxide, recombinant human activated protein C, ibuprofen, naproxen, acetaminophen, cisatracurium besylate, procysteine, acetylcysteine, inhaled prostacydin, ketoconazole, alprostadil, keratinocyte growth factor, beta-agonists, human monoclonal antibody (mAb) against tissue factor VIIa (TS factor 7a), insulin, perfluorocarbon, budesonide, recombinant human angiotensin-converting enzyme (ACE), recombinant human Clara cell 10 kDa (CC10) protein, tissue plasminogen activator, human mesenchymal stem cells, a nutritional therapy, a combination of omega-3 fatty acids, antioxidants, γ-linolenic acids with isocaloric foods, or mechanical ventilation.
20 . A method of increasing the safety of administering an adrenocorticotropic hormone (ACTH) peptide to a critically ill patient comprising a first dosing of about 4 to about 10 days duration wherein the dose is administered as 64 U once per day or 32 U twice a day, followed by one or more subsequent phases of about 4 to about 10 days duration each wherein each successive phase doses is about 50% of the dose of the preceding phase, followed by a final phase wherein the dose of the preceding phase is maintained and administered at intervals of every other day.
21 . The method of claim 20 , wherein the first phase of dosing is about 7 days duration wherein the dose is administered as 64 u once per day or 32 U twice a day, followed by a second phase of about 7 days duration wherein the daily or twice daily, dose is reduced by about 50%, followed by a third phase of about 7 days duration wherein the daily, or twice daily, dose of the second phase is reduced by about 50% and followed by a fourth phase of about 7 days duration, wherein the dose of the third phase is administered every other day.
22 . The method of claim 20 , wherein the critically ill patient is in hospital intensive care.
23 . The method of claim 20 , wherein the critically ill patient is at risk of developing polyneuropathy, polymyopathy or both.