Impact of Anti-static Chamber/Mask
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in 1-6 year old children.
Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold.
Drug: HFA FP MDI
Device: conventional chamber/mask; anti-static chamber/mask
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma|
- one-hour steady-state plasma concentration of fluticasone after each device
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||September 2003|
Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days. A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry assay. Results evaluated using regression analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307970
|United States, Florida|
|University of Florida Asthma Research Lab|
|Gainesville, Florida, United States, 32610-0486|
|Principal Investigator:||Leslie Hendeles, PharmD||University of Florida|