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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: fluticasone propionate/salmeterol (Drug); salmeterol xinafoate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: See Detailed Description

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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: 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

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Nairobi 00200, Kenya

GSK Investigational Site, Hato Rey 00917, Puerto Rico

GSK Investigational Site, Ponce 00716, Puerto Rico

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 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, San Isidro, Lima Lima 27, Peru

GSK Investigational Site, Covington, Louisiana 70433, United States

GSK Investigational Site, Metairie, Louisiana 70002, 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, 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, Hackensack, New Jersey 07601, 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, Durham, North Carolina 27705, 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, 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

Additional Information

Starting date: October 2004
Last updated: April 15, 2015

Page last updated: August 23, 2015

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