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| Sponsor: | University of Florida |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00308932 |
Purpose
To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in children of different ages. Hypothesis -- passive inhalation in younger children through a valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: HFA FP MDI |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Relative Amount of Fluticasone Delivered by HFA-MDI Through Chamber/Mask to Young Children With Asthma |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | April 2004 |
The objective was to determine the effect of age and device on delivery of fluticasone propionate delivered by HFA-pMDI in children of different ages. The one-hour steady-state fluticasone plasma concentration which is an indirect measure of airway delivery and direct measure of systemic exposure, was determined. Sixty children with well-controlled persistent asthma received two actuations of 110 mcg twice daily for at least 3 days. A blood sample was collected one hour after the last dose when 100% adherence was documented by electronic monitor. Five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by actuator alone; 3) 5-9 yr by antistatic VHC/mouthpiece; 4) 5-9 yr by antistatic VHC/mask and 5) 1-4 yr by antistatic VHC/mask. Fluticasone concentrations were measured by LC-MS/MS assay. Fluticasone plasma concentration between groups was compared using one way ANOVA.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:children 1-18 yr, adequately controlled persistent asthma, demonstrate effective administration technique in accordance with the group assigned -
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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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: | 38-2002 |
| Study First Received: | March 28, 2006 |
| Last Updated: | March 28, 2006 |
| ClinicalTrials.gov Identifier: | NCT00308932 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
fluticasone asthma therapy spacer inhaler HFA-134a |
|
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity |
Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |
