Study Of Asthma In Patients Of African Descent - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00102765

Purpose

This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)

Condition	Intervention	Phase
Asthma	Drug: fluticasone propionate/salmeterol powder Drug: fluticasone propionate powder	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Asthma exacerbation rate per patient per year

Secondary Outcome Measures:

Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days

Estimated Enrollment:	460
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	12 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

History of asthma for at least 6 months.
Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).

Exclusion criteria:

History of life-threatening asthma.
Hospitalized for asthma within 3 months prior to the study.
Current respiratory tract infection.
Will not be able to attend clinic visits for the entire length of the study.
Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102765

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Locations

United States, Alabama
GSK Investigational Site
Montgomery, Alabama, United States, 36106
GSK Investigational Site
Muscle Shoals, Alabama, United States, 35662
GSK Investigational Site
Mobile, Alabama, United States, 36608
GSK Investigational Site
Birmingham, Alabama, United States, 35294-0012
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72204
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
Palmdale, California, United States, 93551
GSK Investigational Site
Stockton, California, United States, 95207
GSK Investigational Site
San Francisco, California, United States, 94102
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Connecticut
GSK Investigational Site
Hartford, Connecticut, United States, 06105
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20060
GSK Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32205
GSK Investigational Site
Tallahassee, Florida, United States, 32308
United States, Georgia
GSK Investigational Site
Columbus, Georgia, United States, 31904
GSK Investigational Site
Savannah, Georgia, United States, 31406
GSK Investigational Site
Decatur, Georgia, United States, 30030
GSK Investigational Site
Martinez, Georgia, United States, 30907
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
GSK Investigational Site
Flossmoor, Illinois, United States, 60422
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
GSK Investigational Site
Picayune, Mississippi, United States, 39466
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
GSK Investigational Site
Verona, New Jersey, United States, 07044
United States, New York
GSK Investigational Site
Brooklyn, New York, United States, 11215
GSK Investigational Site
West Sayville, New York, United States, 11796
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Elizabeth City, North Carolina, United States, 27909
GSK Investigational Site
High Point, North Carolina, United States, 27262
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
GSK Investigational Site
Jenkintown, Pennsylvania, United States, 19406
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104-6160
United States, South Carolina
GSK Investigational Site
Greenville, South Carolina, United States, 29607
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
GSK Investigational Site
Charleston, South Carolina, United States, 29407
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Houston, Texas, United States, 77054
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
GSK Investigational Site
Newport News, Virginia, United States, 23601
GSK Investigational Site
Richmond, Virginia, United States, 23229
GSK Investigational Site
Richmond, Virginia, United States, 23225
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bailey W, Castro M, Matz J, White M, Dransfield M, Yancey S, Ortega H. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008 Jun;24(6):1669-82. Epub 2008 May 6.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SFA103153
Study First Received:	February 1, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00102765 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

asthma
asthma exacerbation

Additional relevant MeSH terms:

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

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
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 November 30, 2009