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

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)

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: fluticasone propionate/salmeterol powder; Drug: fluticasone propionate powder

• Study Type: Interventional
• Enrollment (Actual): 479
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35209
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35294-0012
      • GSK Investigational Site
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
    • Montgomery, Alabama, United States, 36106
      • GSK Investigational Site
    • Muscle Shoals, Alabama, United States, 35662
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
    • Little Rock, Arkansas, United States, 72204
      • GSK Investigational Site
  • California
    • Long Beach, California, United States, 90806
      • GSK Investigational Site
    • Los Angeles, California, United States, 90048
      • GSK Investigational Site
    • Palmdale, California, United States, 93551
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • San Francisco, California, United States, 94102
      • GSK Investigational Site
    • Stockton, California, United States, 95207
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • GSK Investigational Site
    • Washington, District of Columbia, United States, 20060
      • GSK Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32205
      • GSK Investigational Site
    • Tallahassee, Florida, United States, 32308
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Columbus, Georgia, United States, 31904
      • GSK Investigational Site
    • Decatur, Georgia, United States, 30030
      • GSK Investigational Site
    • Martinez, Georgia, United States, 30907
      • GSK Investigational Site
    • Savannah, Georgia, United States, 31406
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • GSK Investigational Site
    • Flossmoor, Illinois, United States, 60422
      • GSK Investigational Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • GSK Investigational Site
    • Metairie, Louisiana, United States, 70006
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • GSK Investigational Site
    • Bethesda, Maryland, United States, 20814
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
    • Ypsilanti, Michigan, United States, 48197
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
    • Picayune, Mississippi, United States, 39466
      • GSK Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • GSK Investigational Site
  • New York
    • Brooklyn, New York, United States, 11215
      • GSK Investigational Site
    • New York, New York, United States, 10032
      • GSK Investigational Site
    • West Sayville, New York, United States, 11796
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28204
      • 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
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44106
      • GSK Investigational Site
    • Sylvania, Ohio, United States, 43560
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • GSK Investigational Site
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19406
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19102
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104-6160
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • GSK Investigational Site
    • Charleston, South Carolina, United States, 29406-7108
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29607
      • GSK Investigational Site
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • GSK Investigational Site
    • Knoxville, Tennessee, United States, 37909
      • GSK Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37203-1424
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37208
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78750
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • Houston, Texas, United States, 77054
      • GSK Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23601
      • GSK Investigational Site
    • Norfolk, Virginia, United States, 23507
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23225
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23229
      • GSK Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Asthma exacerbation rate per patient per year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: February 1, 2005
• First Submitted That Met QC Criteria: February 1, 2005
• First Posted (Estimate): February 2, 2005

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 16, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: asthma; asthma exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: SFA103153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: SFA103153
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register