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

This study has been completed.

First Received on November 15, 2006. Last Updated on March 17, 2011 History of Changes

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Intervention Details:

Other Names:

ADVAIR HFA
ADVAIR DISKUS

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:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00400608 History of Changes
Other Study ID Numbers:	SAS105519
Study First Received:	November 15, 2006
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

pediatrics
ADVAIR Inhaler
Asthma
ADVAIR DISKUS

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone, salmeterol drug combination
Albuterol
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Tocolytic Agents
Reproductive Control Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 09, 2012