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CompletedNCT00102765Updated Jan 18, 2017

Study Of Asthma In Patients Of African Descent

A Phase 4 interventional study of fluticasone propionate/salmeterol powder and fluticasone propionate powder in Asthma, sponsored by GlaxoSmithKline. Completed at 75 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
479
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Asthma

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Keywords

  • asthma exacerbation
  • asthma
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 479 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
479 participants (actual)

Interventions

  • Drugfluticasone propionate/salmeterol powder
  • Drugfluticasone propionate powder

    Also known as: fluticasone propionate/salmeterol powder

06

What researchers measure

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

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Study locations

75 sites
  • 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, District of Columbia 20010, United States
  • GSK Investigational Site
    Washington, 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
08

References and documents

Publications

  • 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. PubMed 18462564 ↗
  • Anderson 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. PubMed 23706709 ↗
  • Camargo 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. PubMed 20429821 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00102765
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 2, 2005
Start date
Nov 2004
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Jan 18, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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