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Effect of Age and Device on Delivery of Fluticasone

NCT ID: NCT00308932

Last Updated: 2011-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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HFA FP MDI

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Hendeles, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida Asthma Research Lab

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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38-2002

Identifier Type: -

Identifier Source: org_study_id

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