Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307970
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2006-03-24
Brief Title:
Impact of Anti-static ChamberMask
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma
Status:
COMPLETED
Status Verified Date:
2004-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare lung delivery of fluticasone propionate delivered by HFA-pMDI using a conventional polycarbonate of anti-static chambermask in a randomized crossover design in 1-6 year old children
Hypothesis Anti-static chambermask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold
Hypothesis Anti-static chambermask would increase the amount of inhaled corticosteroid delivered to young children who passively inhale and cannot breath hold
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None