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Impact of Anti-static Chamber/Mask

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00307970
First received: March 24, 2006
Last updated: September 16, 2011
Last verified: June 2004
History of Changes

March 24, 2006
September 16, 2011
April 2003
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one-hour steady-state plasma concentration of fluticasone after each device
Same as current
Complete list of historical versions of study NCT00307970 on ClinicalTrials.gov Archive Site
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Impact of Anti-static Chamber/Mask
The Impact of an Anti-static Valved-holding Chamber on Bioavailability of Inhaled Fluticasone Propionate in Young Children With Asthma

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: HFA FP MDI
  • Device: conventional chamber/mask; anti-static chamber/mask
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
September 2003
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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
Both
1 Year to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00307970
582-2002
Not Provided
University of Florida
University of Florida
GlaxoSmithKline
Principal Investigator: Leslie Hendeles, PharmD University of Florida
University of Florida
June 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP