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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00400608 |
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
Condition | Intervention | Phase |
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Asthma |
Drug: ADVAIR HFA Drug: ADVAIR DISKUS |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | See Detailed Description |
Enrollment: | 28 |
Study Start Date: | October 2006 |
Study Completion Date: | February 2007 |
A repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2 inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily
Ages Eligible for Study: | 4 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, California | |
GSK Investigational Site | |
Huntington Beach, California, United States, 92647 | |
GSK Investigational Site | |
Long Beach, California, United States, 90806 | |
United States, Oregon | |
GSK Investigational Site | |
Medford, Oregon, United States, 97504 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SAS105519 |
Study First Received: | November 15, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00400608 |
Health Authority: | United States: Food and Drug Administration |
Asthma pediatrics ADVAIR DISKUS ADVAIR Inhaler |
Hypersensitivity Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases |
Albuterol Hypersensitivity, Immediate Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Physiological Effects of Drugs Anti-Asthmatic Agents |
Anti-Allergic Agents Reproductive Control Agents Adrenergic Agonists Pharmacologic Actions Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |