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CompletedNCT00102882Updated Feb 3, 2017

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

A Phase 4 interventional study of fluticasone propionate/salmeterol and salmeterol xinafoate in Asthma, sponsored by GlaxoSmithKline. Completed at 91 sites in 4 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-02-03.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
547
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Asthma

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Keywords

  • genotype
  • Salmeterol
  • ADVAIR
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 547 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.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

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

Interventions

  • Drugfluticasone propionate/salmeterol
  • Drugsalmeterol xinafoate

    Also known as: fluticasone propionate/salmeterol

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

91 sites
  • GSK Investigational Site
    Mobile, Alabama 36608, United States
  • GSK Investigational Site
    Little Rock, Arkansas 72205, United States
  • GSK Investigational Site
    Fresno, California 93720, United States
  • GSK Investigational Site
    Fullerton, California 92835, United States
  • GSK Investigational Site
    Huntington Beach, California 92647, United States
  • GSK Investigational Site
    Inglewood, California 90301, United States
  • GSK Investigational Site
    Irvine, California 92618, United States
  • GSK Investigational Site
    Long Beach, California 90806, United States
  • GSK Investigational Site
    Long Beach, California 90808, United States
  • GSK Investigational Site
    Los Angeles, California 90025, United States
  • GSK Investigational Site
    Los Angeles, California 90048, United States
  • GSK Investigational Site
    Orange, California 92868, United States
  • GSK Investigational Site
    Spring Valley, California 91978, United States
  • GSK Investigational Site
    Stockton, California 95207, United States
  • GSK Investigational Site
    Colorado Springs, Colorado 80907, United States
  • GSK Investigational Site
    Denver, Colorado 80206, United States
  • GSK Investigational Site
    Denver, Colorado 80209, United States
  • GSK Investigational Site
    Lakewood, Colorado 80401, United States
  • GSK Investigational Site
    Wheat Ridge, Colorado 80033, United States
  • GSK Investigational Site
    Waterbury, Connecticut 06708, United States
  • GSK Investigational Site
    Coral Gables, Florida 33134, United States
  • GSK Investigational Site
    Jacksonville, Florida 32207, United States
  • GSK Investigational Site
    Miami, Florida 33136, United States
  • GSK Investigational Site
    Miami, Florida 33176, United States
  • GSK Investigational Site
    Orlando, Florida 32806, United States
  • GSK Investigational Site
    Sarasota, Florida 34233, United States
  • GSK Investigational Site
    South Miami, Florida 33143, United States
  • GSK Investigational Site
    Tallahassee, Florida 32308, United States
  • GSK Investigational Site
    Tampa, Florida 33613, United States
  • GSK Investigational Site
    Atlanta, Georgia 30310, United States
  • GSK Investigational Site
    Lawrenceville, Georgia 30045, United States
  • GSK Investigational Site
    Lilburn, Georgia 30047, United States
  • GSK Investigational Site
    Chicago, Illinois 60612, United States
  • GSK Investigational Site
    Chicago, Illinois 60637, United States
  • GSK Investigational Site
    Indianapolis, Indiana 46208, United States
  • GSK Investigational Site
    Overland Park, Kansas 66210, United States
  • GSK Investigational Site
    Covington, Louisiana 70433, United States
  • GSK Investigational Site
    Metairie, Louisiana 70002, United States
  • GSK Investigational Site
    Shreveport, Louisiana 71104, United States
  • GSK Investigational Site
    Shreveport, Louisiana 71105, United States
  • GSK Investigational Site
    Baltimore, Maryland 21201, United States
  • GSK Investigational Site
    Baltimore, Maryland 21237, United States
  • GSK Investigational Site
    Boston, Massachusetts 02118, United States
  • GSK Investigational Site
    North Dartmouth, Massachusetts 02747, United States
  • GSK Investigational Site
    Jackson, Mississippi 39202, United States
  • GSK Investigational Site
    Columbia, Missouri 65203, United States
  • GSK Investigational Site
    St. Louis, Missouri 63141, United States
  • GSK Investigational Site
    Warrensburg, Missouri 64093, United States
  • GSK Investigational Site
    Papillion, Nebraska 68046, United States
  • GSK Investigational Site
    Hackensack, New Jersey 07601, United States
  • GSK Investigational Site
    Newark, New Jersey 07103-2499, United States
  • GSK Investigational Site
    Bayshore, New York 11706, United States
  • GSK Investigational Site
    New York, New York 10021, United States
  • GSK Investigational Site
    Rochester, New York 14618, United States
  • GSK Investigational Site
    Asheville, North Carolina 28801, United States
  • GSK Investigational Site
    Winston-Salem, North Carolina 27157, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73120, United States
  • GSK Investigational Site
    Medford, Oregon 97504, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19143, United States
  • GSK Investigational Site
    Upland, Pennsylvania 19013, United States
  • GSK Investigational Site
    Charleston, South Carolina 29407, United States
  • GSK Investigational Site
    Charleston, South Carolina 29414, United States
  • GSK Investigational Site
    Orangeburg, South Carolina 29118, United States
  • GSK Investigational Site
    Spartanburg, South Carolina 29303, United States
  • GSK Investigational Site
    Chattanooga, Tennessee 37421, United States
  • GSK Investigational Site
    Knoxville, Tennessee 37920, United States
  • GSK Investigational Site
    Nashville, Tennessee 37203-1424, United States
  • GSK Investigational Site
    Corsicana, Texas 75110, United States
  • GSK Investigational Site
    Dallas, Texas 75230, United States
  • GSK Investigational Site
    Dallas, Texas 75246, United States
  • GSK Investigational Site
    El Paso, Texas 79902, United States
  • GSK Investigational Site
    El Paso, Texas 79925, United States
  • GSK Investigational Site
    Fort Worth, Texas 76104, United States
  • GSK Investigational Site
    Houston, Texas 77054, United States
  • GSK Investigational Site
    Kerrville, Texas 78028, United States
  • GSK Investigational Site
    San Antonio, Texas 78229, United States
  • GSK Investigational Site
    South Burlington, Vermont 05403, United States
  • GSK Investigational Site
    Richmond, Virginia 23229, United States
  • GSK Investigational Site
    Bellingham, Washington 98225, United States
  • GSK Investigational Site
    Kirkland, Washington 98034, United States
  • GSK Investigational Site
    Madison, Wisconsin 53792, United States
  • GSK Investigational Site
    Milwaukee, Wisconsin 53209-0996, United States
  • GSK Investigational Site
    Milwaukee, Wisconsin 53219, United States
  • GSK Investigational Site
    Milwaukee, Wisconsin 53226, United States
  • GSK Investigational Site
    West Allis, Wisconsin 53227, United States
  • GSK Investigational Site
    Nairobi, 00200, Kenya
  • GSK Investigational Site
    San Isidro, Lima Lima 27, Peru
  • GSK Investigational Site
    Lima, Lima 1, Peru
  • GSK Investigational Site
    Hato Rey, 00917, Puerto Rico
  • GSK Investigational Site
    Ponce, 00716, Puerto Rico
08

References and documents

Publications

  • Bleecker ER, Nelson HS, Kraft M, Corren J, Meyers DA, Yancey SW, Anderson WH, Emmett AH, Ortega HG. Beta2-receptor polymorphisms in patients receiving salmeterol with or without fluticasone propionate. Am J Respir Crit Care Med. 2010 Apr 1;181(7):676-87. doi: 10.1164/200809-1511OC. Epub 2009 Nov 12. PubMed 19910613 ↗

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00102882
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 4, 2005
Start date
Oct 2004
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Feb 3, 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 Feb 2017. You cannot join it, but the record below documents what was studied.

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