Impact of Anti-Static Chamber/Mask - Full Text View

Sponsors and Collaborators:	University of Florida GlaxoSmithKline
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00307970

Purpose

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
Asthma	Drug: HFA FP MDI Device: conventional chamber/mask; anti-static chamber/mask	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate HFA 227

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307970

Locations

United States, Florida
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610-0486

Sponsors and Collaborators

University of Florida

GlaxoSmithKline

Investigators

Principal Investigator:

Leslie Hendeles, PharmD

University of Florida

More Information

Study ID Numbers:	582-2002
Study First Received:	March 24, 2006
Last Updated:	March 24, 2006
ClinicalTrials.gov Identifier:	NCT00307970
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Florida:

fluticasone
asthma therapy
spacer inhaler
HFA-134a

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009