Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102882
First received: February 3, 2005
Last updated: October 4, 2012
Last verified: September 2012
  Purpose

This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.


Condition Intervention Phase
Asthma
Drug: fluticasone propionate/salmeterol
Drug: salmeterol xinafoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT

Secondary Outcome Measures:
  • Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT

Estimated Enrollment: 540
Study Start Date: October 2004
Intervention Details:
    Drug: fluticasone propionate/salmeterol Drug: salmeterol xinafoate
    Other Names:
    • fluticasone propionate/salmeterol
    • salmeterol xinafoate
Detailed Description:

A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 100/50mcg or Salmeterol DISKUS 50 mcg BID

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of persistent asthma for 3 months.
  • Use of short-acting beta-agonist medication like VENTOLIN.

Exclusion criteria:

  • Hospitalization for asthma 6 months before study.
  • Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
  • Current use of inhaled or oral corticosteroids.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102882

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Inglewood, California, United States, 90301
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
Spring Valley, California, United States, 91978
GSK Investigational Site
Stockton, California, United States, 95207
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Denver, Colorado, United States, 80209
GSK Investigational Site
Denver, Colorado, United States, 80206
GSK Investigational Site
Lakewood, Colorado, United States, 80401
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Jacksonville, Florida, United States, 32207
GSK Investigational Site
Miami, Florida, United States, 33176
GSK Investigational Site
Miami, Florida, United States, 33136
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Sarasota, Florida, United States, 34233
GSK Investigational Site
South Miami, Florida, United States, 33143
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30310
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Lilburn, Georgia, United States, 30047
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60637
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
United States, Louisiana
GSK Investigational Site
Covington, Louisiana, United States, 70433
GSK Investigational Site
Metairie, Louisiana, United States, 70002
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21237
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65203
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
United States, New Jersey
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
United States, New York
GSK Investigational Site
Bayshore, New York, United States, 11706
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
GSK Investigational Site
Asheville, North Carolina, United States, 28801
GSK Investigational Site
Durham, North Carolina, United States, 27705
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19143
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29414
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
United States, Texas
GSK Investigational Site
Corsicana, Texas, United States, 75110
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
El Paso, Texas, United States, 79902
GSK Investigational Site
El Paso, Texas, United States, 79925
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
Kerrville, Texas, United States, 78028
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23229
United States, Washington
GSK Investigational Site
Bellingham, Washington, United States, 98225
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53219
GSK Investigational Site
West Allis, Wisconsin, United States, 53227
Kenya
GSK Investigational Site
Nairobi, Kenya, 00200
Peru
GSK Investigational Site
San Isidro, Lima, Peru, Lima 27
Puerto Rico
GSK Investigational Site
Hato Rey, Puerto Rico, 00917
GSK Investigational Site
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102882     History of Changes
Other Study ID Numbers: SFA100062
Study First Received: February 3, 2005
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Salmeterol
genotype
ADVAIR

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Albuterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on April 15, 2014