Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate
Randomized, Double-Blind Comparison of Advair 100/50 BID vs Salmeterol BID vs Albuterol QID in Subjects With ARG/ARG Genotype 12 Years of Age and Older With Presistent Asthma on Short-Acting Beta2-Agonists Alone
1 other identifier
interventional
547
4 countries
91
Brief 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.
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 Oct 2004
Typical duration for phase_4 asthma
91 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
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 3, 2005
CompletedFirst Posted
Study publicly available on registry
February 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFebruary 3, 2017
February 1, 2017
2.3 years
February 3, 2005
February 2, 2017
Conditions
Keywords
Outcome Measures
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
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of persistent asthma for 3 months.
- Use of short-acting beta-agonist medication like VENTOLIN.
You may not qualify if:
- Hospitalization for asthma 6 months before study.
- Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
- Current use of inhaled or oral corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (91)
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
Bay Shore, 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
Lima, Lima Province, Lima 1, Peru
GSK Investigational Site
San Isidro, Lima region, Lima 27, Peru
GSK Investigational Site
Hato Rey, Puerto Rico, 00917, Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00716, Puerto Rico
Related Publications (1)
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.
PMID: 19910613DERIVED
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 3, 2005
First Posted
February 4, 2005
Study Start
October 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
February 3, 2017
Record last verified: 2017-02
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.