NCT00308932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
Last Updated

September 20, 2011

Status Verified

August 1, 2004

First QC Date

March 28, 2006

Last Update Submit

September 16, 2011

Conditions

Asthma

Keywords

fluticasoneasthma therapyspacer inhalerHFA-134a

Outcome Measures

Primary Outcomes (1)

  • One-hour steady-state plasma concentration of fluticasone

Interventions

HFA FP MDIDRUG

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Asthma Research Lab

Gainesville, Florida, 32610-0486, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Leslie Hendeles, PharmD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 30, 2006

Study Start

February 1, 2003

Study Completion

April 1, 2004

Last Updated

September 20, 2011

Record last verified: 2004-08

Locations

US(1)