Effect of Age and Device on Delivery of Fluticasone
Information source: University of Florida
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: HFA FP MDI (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Florida Official(s) and/or principal investigator(s):
Leslie Hendeles, PharmD, Principal Investigator, Affiliation: University of Florida
Summary
To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in
children of different ages. Hypothesis - - passive inhalation in younger children through a
valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to
airways.
Clinical Details
Official title: Relative Amount of Fluticasone Delivered by HFA-MDI Through Chamber/Mask to Young Children With Asthma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Primary outcome: One-hour steady-state plasma concentration of fluticasone
Detailed description:
The objective was to determine the effect of age and device on delivery of fluticasone
propionate delivered by HFA-pMDI in children of different ages. The one-hour steady-state
fluticasone plasma concentration which is an indirect measure of airway delivery and direct
measure of systemic exposure, was determined. Sixty children with well-controlled persistent
asthma received two actuations of 110 mcg twice daily for at least 3 days. A blood sample
was collected one hour after the last dose when 100% adherence was documented by electronic
monitor. Five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by
actuator alone; 3) 5-9 yr by antistatic VHC/mouthpiece; 4) 5-9 yr by antistatic VHC/mask and
5) 1-4 yr by antistatic VHC/mask. Fluticasone concentrations were measured by LC-MS/MS
assay. Fluticasone plasma concentration between groups was compared using one way ANOVA.
Eligibility
Minimum age: 1 Year.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: children 1-18 yr, adequately controlled persistent asthma, demonstrate
effective administration technique in accordance with the group assigned -
Exclusion Criteria: inadequately controlled asthma: nocturnal awakening >2 nights/month, prn
albuterol use >2x/week, more than 2 short courses of oral corticosteroids in previous 3
months, missing a dose on more than one occasion, increase in asthma symptoms during study,
inability to discontinue intranasal or dermal fluticasone for 3 days
-
Locations and Contacts
University of Florida Asthma Research Lab, Gainesville, Florida 32610-0486, United States
Additional Information
Starting date: February 2003
Ending date: April 2004
Last updated: March 28, 2006
|
