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Advair Pediatric Once-Daily

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

Condition(s) targeted: Asthma

Intervention: FP 100mcg (Drug); FSC 100/50mcg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.

Clinical Details

Official title: A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

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

Primary outcome: Change from baseline at endpoint in daily PM PEF

Secondary outcome: Various pulmonary function endpoints

Eligibility

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Out-patients

- Asthma diagnosis

- Reversibility

- Short-acting beta-agonist or asthma controlled medication use

Exclusion Criteria:

- Life-threatening asthma

- Specified asthma medications

- Chickenpox

- Drug allergy

- Respiratory infections

- Tobacco use

- Clinical laboratory abnormalities

- Ophthalmologic conditions

- Investigation medications

- Affiliation with investigator site

Locations and Contacts

GSK Investigational Site, Buenos Aires 1425, Argentina

GSK Investigational Site, Ciudad Autónoma de Buenos Aires 1425, Argentina

GSK Investigational Site, Santa Fe 3000, Argentina

GSK Investigational Site, Breña Lima 5, Peru

GSK Investigational Site, Ponce 00716, Puerto Rico

GSK Investigational Site, San Juan 00935, Puerto Rico

GSK Investigational Site, Ozark, Alabama 36360, United States

GSK Investigational Site, Tucson, Arizona 85716, United States

GSK Investigational Site, Tucson, Arizona 85746, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Beverly Hills, California 90212, United States

GSK Investigational Site, Crescent City, California 95531, United States

GSK Investigational Site, Dinuba, California 93618, United States

GSK Investigational Site, Fresno, California 93720, United States

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, La Jolla, California 92093, United States

GSK Investigational Site, Long Beach, California 90806, United States

GSK Investigational Site, Mission Viejo, California 92691, United States

GSK Investigational Site, Newport Beach, California 92660, United States

GSK Investigational Site, Orange, California 92868, United States

GSK Investigational Site, Palmdale, California 93551, United States

GSK Investigational Site, Panorama City, California 91402, United States

GSK Investigational Site, Paramount, California 90723, United States

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, Rolling Hills Estates, California 90274, United States

GSK Investigational Site, San Diego, California 92120, United States

GSK Investigational Site, San Francisco, California 94102, United States

GSK Investigational Site, San Jose, California 95117, United States

GSK Investigational Site, Sherman Oaks, California 91403, United States

GSK Investigational Site, Vista, California 92083, United States

GSK Investigational Site, Vista, California 92084, United States

GSK Investigational Site, Walnut Creek, California 94598, United States

GSK Investigational Site, Centennial, Colorado 80112, United States

GSK Investigational Site, Colorado Springs, Colorado 80907, United States

GSK Investigational Site, Denver, Colorado 80218, United States

GSK Investigational Site, Denver, Colorado 80206, United States

GSK Investigational Site, Denver, Colorado 80230, United States

GSK Investigational Site, Pueblo, Colorado 81008, United States

GSK Investigational Site, Altamonte Springs, Florida 32701, United States

GSK Investigational Site, Hialeah, Florida 33013, United States

GSK Investigational Site, Jacksonville, Florida 32216, United States

GSK Investigational Site, Orlando, Florida 32801, United States

GSK Investigational Site, Orlando, Florida 32806, United States

GSK Investigational Site, Sarasota, Florida 34233, United States

GSK Investigational Site, St. Petersburg, Florida 33710, United States

GSK Investigational Site, Tallahassee, Florida 32308, United States

GSK Investigational Site, Tampa, Florida 33613, United States

GSK Investigational Site, Atlanta, Georgia 30309-7520, United States

GSK Investigational Site, Augusta, Georgia 30901, United States

GSK Investigational Site, Barnesville, Georgia 30204, United States

GSK Investigational Site, Martinez, Georgia 30907, United States

GSK Investigational Site, Savannah, Georgia 31406, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Glenview, Illinois 60025, United States

GSK Investigational Site, Hoffman Estates, Illinois 60195, United States

GSK Investigational Site, Park Ridge, Illinois 60068, United States

GSK Investigational Site, Indianapolis, Indiana 46208, United States

GSK Investigational Site, South Bend, Indiana 46617, United States

GSK Investigational Site, Lawrence, Kansas 66047, United States

GSK Investigational Site, Louisville, Kentucky 40222, United States

GSK Investigational Site, Murray, Kentucky 42071, United States

GSK Investigational Site, Covington, Louisiana 70433, United States

GSK Investigational Site, Metairie, Louisiana 70001, United States

GSK Investigational Site, Metairie, Louisiana 70006, United States

GSK Investigational Site, Shreveport, Louisiana 71104, United States

GSK Investigational Site, Sunset, Louisiana 70584, United States

GSK Investigational Site, Newton, Massachusetts 02462, United States

GSK Investigational Site, North Dartmouth, Massachusetts 02747, United States

GSK Investigational Site, Taunton, Massachusetts 02780, United States

GSK Investigational Site, West Quincy, Massachusetts 02169, United States

GSK Investigational Site, Detroit, Michigan 48202, United States

GSK Investigational Site, Minneapolis, Minnesota 55416, United States

GSK Investigational Site, Columbia, Missouri 65212, United States

GSK Investigational Site, Kansas City, Missouri 64108, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, St. Louis, Missouri 63139, United States

GSK Investigational Site, St. Louis, Missouri 63108, United States

GSK Investigational Site, Missoula, Montana 59804, United States

GSK Investigational Site, Omaha, Nebraska 68130, United States

GSK Investigational Site, Omaha, Nebraska 68134, United States

GSK Investigational Site, Papillion, Nebraska 68046, United States

GSK Investigational Site, Berlin, New Jersey 08009, United States

GSK Investigational Site, Brick, New Jersey 8724, United States

GSK Investigational Site, East Orange, New Jersey 7017, United States

GSK Investigational Site, Ocean, New Jersey 07712, United States

GSK Investigational Site, Verona, New Jersey 7044, United States

GSK Investigational Site, Albuquerque, New Mexico 87131, United States

GSK Investigational Site, Buffalo, New York 14222, United States

GSK Investigational Site, Liverpool, New York 13088, United States

GSK Investigational Site, New Hyde Park, New York 11042, United States

GSK Investigational Site, Rockville Center, New York 11570, United States

GSK Investigational Site, Vestal, New York 13850, United States

GSK Investigational Site, Asheville, North Carolina 28801, United States

GSK Investigational Site, Charlotte, North Carolina 28204, United States

GSK Investigational Site, Durham, North Carolina 27704, United States

GSK Investigational Site, Elizabeth City, North Carolina 27909, United States

GSK Investigational Site, Winston-Salem, North Carolina 27103, United States

GSK Investigational Site, Canton, Ohio 44718, United States

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Cleveland, Ohio 44106, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73120, United States

GSK Investigational Site, Bend, Oregon 97701, United States

GSK Investigational Site, Medford, Oregon 97504, United States

GSK Investigational Site, Portland, Oregon 97213, United States

GSK Investigational Site, Portland, Oregon 97223, United States

GSK Investigational Site, Altoona, Pennsylvania 16601, United States

GSK Investigational Site, Blue Belle, Pennsylvania 19422, United States

GSK Investigational Site, Harrisburg, Pennsylvania 17110, United States

GSK Investigational Site, Lewisburg, Pennsylvania 17837, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19135, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15202, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15241, United States

GSK Investigational Site, Upland, Pennsylvania 19013, United States

GSK Investigational Site, Santiago, Región Metro De Santiago, Chile

GSK Investigational Site, Lincoln, Rhode Island 02865-4208, United States

GSK Investigational Site, Charleston, South Carolina 29407, United States

GSK Investigational Site, Greenville, South Carolina 29607, United States

GSK Investigational Site, Mount Pleasant, South Carolina 29464, United States

GSK Investigational Site, Spartanburg, South Carolina 29303, United States

GSK Investigational Site, Knoxville, Tennessee 37916, United States

GSK Investigational Site, Knoxville, Tennessee 37917, United States

GSK Investigational Site, Knoxville, Tennessee 37922, United States

GSK Investigational Site, Austin, Texas 78749, United States

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, El Paso, Texas 79902, United States

GSK Investigational Site, El Paso, Texas 79925, United States

GSK Investigational Site, Galveston, Texas 77555-0188, United States

GSK Investigational Site, Houston, Texas 77074, United States

GSK Investigational Site, Houston, Texas 77054, United States

GSK Investigational Site, Houston, Texas 77065, United States

GSK Investigational Site, Lake Jackson, Texas 77566, United States

GSK Investigational Site, New Braunfels, Texas 78130, United States

GSK Investigational Site, Plano, Texas 75093, United States

GSK Investigational Site, San Antonio, Texas 78205, United States

GSK Investigational Site, San Antonio, Texas 78207, United States

GSK Investigational Site, San Antonio, Texas 78233, United States

GSK Investigational Site, Layton, Utah 84041, United States

GSK Investigational Site, Murray, Utah 84107, United States

GSK Investigational Site, Viña del Mar, Valparaíso, Chile

GSK Investigational Site, Burke, Virginia 22015, United States

GSK Investigational Site, Norfolk, Virginia 23510, United States

GSK Investigational Site, Richmond, Virginia 23229, United States

GSK Investigational Site, Richmond, Virginia 23298, United States

GSK Investigational Site, Edmonds, Washington 98026, United States

GSK Investigational Site, Tacoma, Washington 98405, United States

GSK Investigational Site, Charleston, West Virginia 25301, United States

GSK Investigational Site, Greenfield, Wisconsin 53228, United States

GSK Investigational Site, La Crosse, Wisconsin 54601, United States

Additional Information

Related publications:

This study has not been published in the scientific literature.

Starting date: November 2001
Last updated: December 5, 2013

Page last updated: August 23, 2015

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