Effect of Age and Device on Delivery of Fluticasone - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 28, 2006

Last Updated Date

March 28, 2006

Start Date ^†

February 2003

Current Primary Outcome Measures ^†

One-hour steady-state plasma concentration of fluticasone

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Effect of Age and Device on Delivery of Fluticasone

Official Title ^†

Relative Amount of Fluticasone Delivered by HFA-MDI Through Chamber/Mask to Young Children With Asthma

Brief 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.

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^†

Asthma

Intervention ^†

Drug: HFA FP MDI

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

April 2004

Primary Completion Date

Eligibility 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

Gender

Both

Ages

1 Year to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00308932

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Florida

Collaborators ^††

GlaxoSmithKline

Investigators ^†

Principal Investigator:

Leslie Hendeles, PharmD

University of Florida

Information Provided By

University of Florida

Verification Date

August 2004

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.