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Urinary fluticasone propionate-17beta-carboxylic acid to assess asthma therapy adherence.

Abstract
Although the National Asthma Education and Prevention Program Expert Panel Report 3 recommends referral to specialists to address adherence, guidelines do not provide a tool to determine nonadherence. This study was designed to prospectively evaluate the characteristics of urinary analysis of fluticasone propionate-17beta-carboxylic acid (FP17betaCA) as a test to verify if a specific patient has not taken fluticasone propionate (FP) within 16-24 hours. Urine of asthmatic subjects was prospectively analyzed 16-24 hours after witnessed administration of orally inhaled FP using liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis; limit of quantitation was 10.3 pg/mL. Results were compared with those from asthmatic subjects not receiving inhaled FP. Thirty asthmatic subjects receiving inhaled FP (2 oral inhalations of FP at 110 micrograms each or 1 oral inhalation twice daily of fluticasone and salmeterol in fixed combination at 250/50 micrograms for 1 week) were compared with 30 asthmatic subjects not receiving FP. FP17betaCA was detected in the urine of 30 of 30 asthmatic subjects receiving FP (median, interquartile range [IQR; 413.5, 212.8-1230.0] range 12.4-3290.0 pg/mL [corrected for urine creatinine: median, IQR {576.2, 188.1-1306.6} range 6.3-5425.9 ng/g Cr]) and was undetectable in 30 of 30 subjects not receiving inhaled FP. The sensitivity and specificity of LC-MS/MS to detect FP17betaCA in urine were 100% (95% exact binomial confidence interval, 88-100) and 100% (95% exact binomial confidence interval, 88-100), respectively. Analysis of FP17betaCA in urine provides a sensitive method that may be used to verify that a specific patient may not have administered FP within a 16- to 24-hour window before testing.
AuthorsJohn B Hagan, Brian C Netzel, Marc R Matthews, Nichole L Korpi-Steiner, Ravinder J Singh
JournalAllergy and asthma proceedings (Allergy Asthma Proc) 2012 Jul-Aug Vol. 33 Issue 4 Pg. e35-9 ISSN: 1539-6304 [Electronic] United States
PMID22856629 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Androstadienes
  • Anti-Asthmatic Agents
  • fluticasone propionate-17-carboxylic acid
Topics
  • Adult
  • Androstadienes (administration & dosage, therapeutic use, urine)
  • Anti-Asthmatic Agents (administration & dosage, therapeutic use, urine)
  • Asthma (drug therapy, urine)
  • Drug Administration Schedule
  • Female
  • Gas Chromatography-Mass Spectrometry (methods)
  • Humans
  • Male
  • Middle Aged
  • Patient Compliance
  • Sensitivity and Specificity

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