Overview

Effect of Age and Device on Delivery of Fluticasone

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Collaborator:
GlaxoSmithKline
Treatments:
Fluticasone
Criteria
Inclusion Criteria:children 1-18 yr, adequately controlled persistent asthma, demonstrate
effective administration technique in accordance with the group assigned -

Exclusion Criteria: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

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