We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Impact of Anti-static Chamber/Mask

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00307970
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):
University of Florida

March 24, 2006
March 28, 2006
September 20, 2011
April 2003
Not Provided
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
Not Provided
Not Provided
Not Provided
Not Provided
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.
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: HFA FP MDI
  • Device: conventional chamber/mask; anti-static chamber/mask
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2003
Not Provided

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
Sexes Eligible for Study: All
1 Year to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
University of Florida
University of Florida
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