Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00766090

Purpose

The purpose of this study is to compare once and twice daily GW685698 in asthma

Condition	Intervention	Phase
Asthma	Drug: GW685698X	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Corticosteroids

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multi-Centre, Randomized, Double Blind Cross-Over Study to Assess the Non-Inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

safety and efficacy [ Time Frame: study duration ] [ Designated as safety issue: No ]

Estimated Enrollment:	375
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GW685698X: Experimental	Drug: GW685698X Inhaled Corticosteroid

Eligibility

Criteria

Key Inclusion Criteria:

Clinical diagnosis of Asthma
Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
FEV1 between 40-85% predicted
Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766090

Locations

United States, California
GSK Investigational Site
Torrance, California, United States, 90505
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Long Beach, California, United States, 90808
United States, Florida
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Cocoa, Florida, United States, 32927
United States, Maryland
GSK Investigational Site
Bethesda, Maryland, United States, 20814
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65203
GSK Investigational Site
Rolla, Missouri, United States, 65401
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
Boerne, Texas, United States, 78006
GSK Investigational Site
Waco, Texas, United States, 76712

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	112202
Study First Received:	October 2, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00766090
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009