{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,14]],"date-time":"2024-08-14T13:17:22Z","timestamp":1723641442213},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2013,3,8]],"date-time":"2013-03-08T00:00:00Z","timestamp":1362700800000},"content-version":"vor","delay-in-days":4694,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2000,5]]},"abstract":"<jats:p>The impending phaseout of chlorofluorocarbons as propellants in pressurized metered\u2010dose inhalers used in the treatment of asthma has resulted in the development of alternative devices to deliver drug to the pulmonary airways. These alternative devices include metered\u2010dose inhalers using environmentally friendly hydroflurocarbon propellants and breath\u2010actuated dry\u2010powder inhalers. The purpose of this study was to compare the single\u2010 and multiple\u2010dose pharmacokinetics, pharmacodynamics, and tolerability of a newly developed hydroflurocarbon formulation of triamcinolone acetonide (Azmacort\u00ae HFA 225 mcg Inhalation Aerosol) to that of the dry\u2010powder formulation of budesonide (Pulmicort\u00ae Turbuhaler 200 mcg). This three\u2010way crossover study used 18 normal healthy subjects each receiving a 675 mcg dose of triamcinolone acetonide, 600 mcg dose of budesonide, or placebo twice a day for 5 days. Serial plasma samples were collected after the first and last dose of test medication for pharmacokinetic analysis. Pharmacodynamics were assessed by changes in hypothalamic\u2010pituitary\u2010adrenal axis function as measured by 8 a.m. serum cortisol, 24\u2010hour overnight serum cortisol AL\/C(0.24), and 24\u2010hour urinary\u2010free cortisol after the last evening dose of test drug. Tolerability was assessed through physical examinations, vital signs, 12\u2010lead ECG, routine clinical labs, and adverse events recording. Both compounds were systemically absorbed. However, no significant drug accumulation was noted with chronic dosing. Chronic dosing did result in a statistically significant 20% reduction in basal 24\u2010hour serum cortisol AUC<jats:sub>(0\u201324)<\/jats:sub> for both compounds. There were no clinically significant abnormalities in physical examination, vital signs, 12\u2010lead ECG, or routine clinical labs noted during the study. Overall, the study drugs were well tolerated, with adverse events characterized as mild to moderate in severity.<\/jats:p>","DOI":"10.1177\/00912700022009134","type":"journal-article","created":{"date-parts":[[2003,7,19]],"date-time":"2003-07-19T09:38:13Z","timestamp":1058607493000},"page":"516-526","source":"Crossref","is-referenced-by-count":17,"title":["A Study Comparing the Clinical Pharmacokinetics, Pharmacodynamics, and Tolerability of Triamcinolone Acetonide HFA\u2010134a Metered\u2010Dose Inhaler and Budesonide Dry\u2010Powder Inhaler following Inhalation Administration"],"prefix":"10.1002","volume":"40","author":[{"given":"Domenick","family":"Argenti","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bharti","family":"Shah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald","family":"Heald","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,3,8]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199503303321307"},{"key":"e_1_2_1_3_2","volume-title":"Inhaled Glucocorticoids in Asthma","author":"Brattsand R","year":"1997"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1038\/249810a0"},{"key":"e_1_2_1_5_2","volume-title":"Aerosols, Sterillants, and Miscellaneous Uses of Freons (Pursuant to the Montreal Protocol)","author":"Technology Review Panel\/Technical Options Committee on Aerosols, 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