Effect of Age and Device on Delivery of Fluticasone

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00308932
First received: March 28, 2006
Last updated: September 16, 2011
Last verified: August 2004
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Amount of Fluticasone Delivered by HFA-MDI Through Chamber/Mask to Young Children With Asthma

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • One-hour steady-state plasma concentration of fluticasone

Estimated Enrollment: 60
Study Start Date: February 2003
Estimated Study Completion Date: April 2004
Detailed Description:

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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00308932

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00308932     History of Changes
Other Study ID Numbers: 38-2002
Study First Received: March 28, 2006
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
fluticasone
asthma therapy
spacer inhaler
HFA-134a

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014