Document Detail

Evaluation of the buccal component of systemic absorption with inhaled fluticasone propionate.
MedLine Citation:
PMID:  10377207     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Inhaled corticosteroids have dose related systemic effects determined by oral (swallowed or oropharyngeal absorption) and lung bioavailability. A study was undertaken to evaluate the significance of oropharyngeal absorption for fluticasone propionate. METHODS: Sixteen healthy volunteers of mean age 29.3 years were studied using an open randomised, placebo controlled, four way crossover design. Treatments were: (a) fluticasone metered dose inhaler (pMDI) 250 microg, 8 puffs; (b) fluticasone pMDI 250 microg, 8 puffs + mouth rinsing/gargling (water); (c) fluticasone pMDI 250 microg, 8 puffs + mouth rinsing/gargling (charcoal); and (d) placebo pMDI, 8 puffs + mouth rinsing/gargling (water). Overnight (ONUC) and early morning (EMUC) urinary cortisol/creatinine ratios and 8 am serum cortisol (SC) levels were measured. RESULTS: Significant (p<0. 05) suppression of ONUC, EMUC, and SC occurred with each active treatment compared with placebo. The mean values (95% CI for difference from placebo) were: (a) ONUC (nmol/mmol): fluticasone (2. 8, 95% CI 3.6 to 7.9), fluticasone + water (3.1, 95% CI 3.3 to 7.7), fluticasone + charcoal (2.3, 95% CI 4.1 to 8.5); placebo (8.6); (b) EMUC (nmol/mmol): fluticasone (5.6, 95% CI 8.4 to 24.5), fluticasone + water (7.6, 95% CI 6.6 to 22.4); fluticasone + charcoal (5.6, 95% CI 8.7 to 24.5); placebo (22.1). There were no significant differences between active treatments. The numbers of subjects with an overnight urinary cortisol of <20 nmol/10 hours were 0 (placebo), 11 (fluticasone), 12 (fluticasone + water), and 13 (fluticasone + charcoal). CONCLUSIONS: Oropharyngeal absorption of fluticasone does not significantly contribute to its overall systemic bioactivity as assessed by sensitive measures of adrenal suppression. In view of almost complete hepatic first pass inactivation with fluticasone, there is no rationale to employ mouth rinsing to reduce its systemic effects although it may be of value for reducing oral candidiasis.
O J Dempsey; W J Coutie; A M Wilson; P Williams; B J Lipworth
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Thorax     Volume:  54     ISSN:  0040-6376     ISO Abbreviation:  Thorax     Publication Date:  1999 Jul 
Date Detail:
Created Date:  1999-08-02     Completed Date:  1999-08-02     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0417353     Medline TA:  Thorax     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  614-7     Citation Subset:  IM    
Department of Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK.
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MeSH Terms
Administration, Inhalation
Administration, Topical
Adrenal Glands / drug effects
Analysis of Variance
Androstadienes / pharmacokinetics*
Anti-Inflammatory Agents / pharmacokinetics*
Biological Availability
Confidence Intervals
Creatinine / urine
Cross-Over Studies
Depression, Chemical
Drug Delivery Systems
Hydrocortisone / blood,  urine
Mouth Mucosa / metabolism*
Nebulizers and Vaporizers
Reg. No./Substance:
0/Androstadienes; 0/Anti-Inflammatory Agents; 16291-96-6/Charcoal; 50-23-7/Hydrocortisone; 60-27-5/Creatinine; 7732-18-5/Water; 90566-53-3/fluticasone

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