title: 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.
authors.affiliation: Division of Allergic Diseases, Mayo Clinic, Rochester, Minnesota, USA. hagan.john@mayo.edu
authors.forename: John B
authors.initials: JB
authors.lastname: Hagan
authors.forename: Brian C
authors.initials: BC
authors.lastname: Netzel
authors.forename: Marc R
authors.initials: MR
authors.lastname: Matthews
authors.forename: Nichole L
authors.initials: NL
authors.lastname: Korpi-Steiner
authors.forename: Ravinder J
authors.initials: RJ
authors.lastname: Singh
mesh_terms: D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage* / Q000627:therapeutic use / Q000652:urine*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use / Q000652:urine*; D001249:Asthma / Q000188:drug therapy* / Q000652:urine; D004334:Drug Administration Schedule; D005260:Female; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D012680:Sensitivity and Specificity
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; C549234:fluticasone propionate-17-carboxylic acid