Status:
COMPLETED
Impact of Anti-static Chamber/Mask
Lead Sponsor:
University of Florida
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
1-6 years
Phase:
PHASE4
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. Hyp...
Detailed Description
Objective -- to determine whether an anti-static chamber increases the one-hour steady-state fluticasone plasma concentration, which is an indirect measure of airway delivery and direct measure of sys...
Eligibility Criteria
Inclusion
- 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
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 :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00307970
Start Date
April 1 2003
End Date
September 1 2003
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