Study Of Asthma In Patients Of African Descent
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
1 other identifier
interventional
479
1 country
75
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Nov 2004
Typical duration for phase_4 asthma
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 1, 2005
CompletedFirst Posted
Study publicly available on registry
February 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 18, 2017
January 1, 2017
2.4 years
February 1, 2005
January 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma exacerbation rate per patient per year
Secondary Outcomes (1)
Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (75)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35294-0012, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Muscle Shoals, Alabama, 35662, United States
GSK Investigational Site
Little Rock, Arkansas, 72204, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Palmdale, California, 93551, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
San Francisco, California, 94102, United States
GSK Investigational Site
Stockton, California, 95207, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Hartford, Connecticut, 06105, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20060, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Decatur, Georgia, 30030, United States
GSK Investigational Site
Martinez, Georgia, 30907, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Flossmoor, Illinois, 60422, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Picayune, Mississippi, 39466, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Verona, New Jersey, 07044, United States
GSK Investigational Site
Brooklyn, New York, 11215, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
West Sayville, New York, 11796, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
High Point, North Carolina, 27262, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Jenkintown, Pennsylvania, 19406, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19102, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104-6160, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Greenville, South Carolina, 29607, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Chattanooga, Tennessee, 37421, United States
GSK Investigational Site
Knoxville, Tennessee, 37909, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Nashville, Tennessee, 37203-1424, United States
GSK Investigational Site
Nashville, Tennessee, 37208, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
Newport News, Virginia, 23601, United States
GSK Investigational Site
Norfolk, Virginia, 23507, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Richmond, Virginia, 23229, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
Related Publications (3)
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. doi: 10.1185/03007990802119111. Epub 2008 May 6.
PMID: 18462564BACKGROUNDAnderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.
PMID: 23706709DERIVEDCamargo CA Jr, Sutherland ER, Bailey W, Castro M, Yancey SW, Emmett AH, Stempel DA. Effect of increased body mass index on asthma risk, impairment and response to asthma controller therapy in African Americans. Curr Med Res Opin. 2010 Jul;26(7):1629-35. doi: 10.1185/03007995.2010.483113.
PMID: 20429821DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2005
First Posted
February 2, 2005
Study Start
November 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
January 18, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.