Status:
COMPLETED
Effect of Age and Device on Delivery of Fluticasone
Lead Sponsor:
University of Florida
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
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 ch...
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 conc...
Eligibility Criteria
Inclusion
- children 1-18 yr, adequately controlled persistent asthma, demonstrate effective administration technique in accordance with the group assigned -
Exclusion
- 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
- \-
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00308932
Start Date
February 1 2003
End Date
April 1 2004
Last Update
September 20 2011
Active Locations (1)
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1
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610-0486