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| 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 |
| 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 |
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | September 2003 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of Florida Asthma Research Lab | |
| Gainesville, Florida, United States, 32610-0486 | |
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
fluticasone asthma therapy spacer inhaler HFA-134a |
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Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Lung Diseases |
Hypersensitivity, Immediate Fluticasone Asthma Respiratory Hypersensitivity |
|
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
