Differences in inhaled fluticasone bioavailability between holding chambers in children with asthma.
OBJECTIVE
To determine if differences between holding chambers in previous in vitro aerosol studies would agree with the bioavailability of inhaled fluticasone propionate between the same holding chambers in children with asthma.


METHODS
Double-blind, randomized, crossover study


METHODS
University of Florida Clinical Research Center.


METHODS
Eight children (aged 5-9 yrs) with stable asthma.


METHODS
Under observation, the children inhaled two 110-microg puffs of fluticasone twice/day through the InspirEase or E-Z Spacer holding chamber.


RESULTS
Blood samples were collected at baseline and then at 0.5, 1, 1.5, 2, 4, and 6 hours after the last dose of fluticasone. Primary outcome measures were peak fluticasone steady-state plasma concentration (Cmax) and area under the fluticasone plasma concentration-time curve from 0-6 hours (AUC0-6). The fluticasone plasma concentrations were determined by high-performance liquid chromatography-mass spectrometric assay. Mean +/- SD Cmax from InspirEase (245 +/- 77 pg/ml) was 18% higher than that after E-Z Spacer (199 +/- 58 pg/ml, p < 0.05). Mean +/- SD AUC0-6 from InspirEase (1103 +/- 305 pg x hr(-1) x ml(-1) was 22% higher than that delivered from E-Z Spacer (863 +/- 258 pg x hr(-1) x ml(-1), p = 0.06).


CONCLUSIONS
Differences in inhaled fluticasone bioavailability between these holding chambers in children with asthma corroborate differences reported in earlier in vitro aerosol studies.
Liang
Judy
J
Department of Pharmacy Practice, College of Pharmacy, University of Florida, Gainesville 32610-0486, USA.
Asmus
Michael J
MJ
Hochhaus
Günther
G
Chesrown
Sarah
S
Hendeles
Leslie
L
D000280:Administration, Inhalation; D000336:Aerosols; D000730:Androstadienes / Q000008:administration & dosage / Q000097:blood*; D019540:Area Under Curve; D001249:Asthma / Q000097:blood*; D001682:Biological Availability; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000097:blood*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000068298:Fluticasone; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers
D000336:Aerosols; D000730:Androstadienes; D001993:Bronchodilator Agents; D000068298:Fluticasone