A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS

This study has been completed.

First Received: November 15, 2006 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00400608

Purpose

Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

Condition	Intervention	Phase
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Advair

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS [ Time Frame: 3 Weeks ]

Secondary Outcome Measures:

To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting [ Time Frame: 3 Weeks ]

Enrollment:	28
Study Start Date:	October 2006
Study Completion Date:	February 2007

Detailed Description:

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

Eligibility

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Subjects with mild asthma
No significant medical conditions at screen
Weigh at least 20 kg

Exclusion criteria:

No clinical abnormalities at screen visit
Asthma control at least 3 months prior with anti-steroidal medication only

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400608

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAS105519
Study First Received:	November 15, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00400608 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Asthma
pediatrics
ADVAIR DISKUS
ADVAIR Inhaler

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Albuterol
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents

Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses

Fluticasone
Dermatologic Agents
Salmeterol
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009