Impact of Anti-static Chamber/Mask

This study has been completed.
Information provided by (Responsible Party):
University of Florida Identifier:
First received: March 24, 2006
Last updated: September 16, 2011
Last verified: June 2004

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.

Condition Intervention Phase
Device: conventional chamber/mask; anti-static chamber/mask
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • one-hour steady-state plasma concentration of fluticasone after each device

Estimated Enrollment: 12
Study Start Date: April 2003
Estimated Study Completion Date: September 2003
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 systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered by conventional polycarbonate or anti-static valved-holding chambers with masks in an unblinded, randomized, crossover manner each for at least three days. A blood sample was collected one hour after the last dose when adherence documented by electronic monitor was 100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry assay. Results evaluated using regression analysis.

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 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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Please refer to this study by its identifier: NCT00307970

United States, Florida
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610-0486
Sponsors and Collaborators
University of Florida
Principal Investigator: Leslie Hendeles, PharmD University of Florida
  More Information

Responsible Party: University of Florida Identifier: NCT00307970     History of Changes
Other Study ID Numbers: 582-2002 
Study First Received: March 24, 2006
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
asthma therapy
spacer inhaler
HFA-134a processed this record on May 26, 2016