{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T16:05:19Z","timestamp":1790870719601,"version":"4.1.0"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[1999,3,1]],"date-time":"1999-03-01T00:00:00Z","timestamp":920246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[1999,3,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Since equivalent efficacy is achieved with lower doses of the reformulated beclomethasone dipropionate in the chlorofluorocarbon (CFC)-free propellant HFA-134a (HFA) than with the original CFC-beclomethasone dipropionate formulation, it is possible the HFA-beclomethasone dipropionate may have less safety concerns than the CFC formulation. Despite its chronic use, the steady-state pharmacokinetics of beclomethasone dipropionate has never been studied before. This double-blind study examined adrenal effects and pharmacokinetics after 14 days of dosing with HFA-beclomethasone dipropionate.<\/jats:p>\n               <jats:p>Forty-three steroid-na\u00efve asthmatic patients were randomised into 5 parallel groups and dosed every 12 h for 14 days with: HFA-placebo; 200, 400 or 800 \u03bcg day-1 HFA-beclomethasone dipropionate; or 800 \u03bcg day-1 CFC-beclomethasone dipropionate. After two weeks of dosing, the 24-h urinary free cortisol of all but one patient remained within the normal range, showing that all doses were well tolerated from a systemic safety perspective. The active HFA-beclomethasone dipropionate treatment groups showed a dose-related fall in 24-h urinary free cortisol. Total-beclomethasone (beclomethasone dipropionate and metabolites) pharmacokinetics after either the first dose of HFA-beclomethasone dipropionate or CFC-beclomethasone dipropionate were not substantially affected by subsequent doses. The extent of drug absorption from 800 \u03bcg day-1 HFA-beclomethasone dipropionate and CFC-beclomethasone dipropionate was in the ratio of 1\u20137: 1. A non-linear correlation between 24-h urinary free cortisol and the pharmacokinetic parameters was observed, reflecting smaller changes in 24-h urinary free cortisol than in pharmacokinetics as the dose was increased.<\/jats:p>\n               <jats:p>No clinically meaningful change in the pharmacokinetics of beclomethasone dipropionate plus metabolites was seen on multiple dosing. The greater systemic availability of HFA-beclomethasone dipropionate was still associated with adrenal effects comparable with that of the CFC formulation at the same dose.<\/jats:p>","DOI":"10.1211\/0022357991772439","type":"journal-article","created":{"date-parts":[[2003,7,18]],"date-time":"2003-07-18T23:43:52Z","timestamp":1058571832000},"page":"263-269","source":"Crossref","is-referenced-by-count":38,"title":["Adrenal Effects and Pharmacokinetics of CFC-free Beclomethasone Dipropionate: a 14-Day Dose-Response Study"],"prefix":"10.1093","volume":"51","author":[{"given":"Lester I","family":"Harrison","sequence":"first","affiliation":[{"name":"3M Pharmaceuticals Development Laboratories , St Paul, MN,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gene L","family":"Colice","sequence":"additional","affiliation":[{"name":"3M Pharmaceuticals Development Laboratories , St Paul, MN,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Donnell","sequence":"additional","affiliation":[{"name":"Loughborough ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inmaculada","family":"Soria","sequence":"additional","affiliation":[{"name":"3M Pharmaceuticals Development Laboratories , St Paul, MN,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Dockhorn","sequence":"additional","affiliation":[{"name":"Pharmaceutical Research Associates , Lenexa, KS,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[1999,3,1]]},"reference":[{"key":"2024103110032752200_cit1","doi-asserted-by":"crossref","first-page":"S460","DOI":"10.1016\/S0091-6749(98)70160-5","article-title":"Relative safety and efficacy of inhaled corticosteroids","volume":"101","author":"Barnes","year":"1998","journal-title":"J. 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