NCT00307970

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_4 asthma

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
Last Updated

September 20, 2011

Status Verified

June 1, 2004

First QC Date

March 24, 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 after each device

Interventions

HFA FP MDIDRUG
conventional chamber/mask; anti-static chamber/maskDEVICE

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children 1-6 years old; adequately controlled persistent asthma; currently receiving FP delivered by CFC MDI attached to valved-holding chamber/mask; ability to use chamber with mask effectively

You may not qualify if:

  • 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

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

April 1, 2003

Study Completion

September 1, 2003

Last Updated

September 20, 2011

Record last verified: 2004-06

Locations

US(1)