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Study Of Patients With Allergic Rhinitis And Asthma

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); fluticasone propionate (Drug); montelukast (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 will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

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

Primary outcome: Morning Peak Expiratory Flow

Secondary outcome: Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days

Detailed description: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have asthma for at least 3 months prior to the study.

- Have been using an allowed pre-study asthma therapy for at least 3 months prior to

study.

- Currently have seasonal allergic rhinitis and have had seasonal onset of allergic

rhinitis for at least the two previous allergy seasons.

- Have a positive allergy skin test.

Exclusion Criteria:

- Have a history of life-threatening asthma.

- Been hospitalized for asthma within the 6 months prior to the study.

- Have certain conditions that would make study participation unsafe.

The study doctor will evaluate other inclusion and exclusion criteria.

Locations and Contacts

GSK Investigational Site, Ozark, Alabama 36360, United States

GSK Investigational Site, Tempe, Arizona 85282, United States

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

GSK Investigational Site, Fountain Valley, California 92708, United States

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

GSK Investigational Site, Long Beach, California 90808, United States

GSK Investigational Site, Los Angeles, California 90095-1752, United States

GSK Investigational Site, Orange, California 92868, United States

GSK Investigational Site, Palmdale, California 93551, United States

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, San Diego, California 92123, United States

GSK Investigational Site, San Jose, California 95128, United States

GSK Investigational Site, Stockton, California 95207, United States

GSK Investigational Site, Vista, California 92083, United States

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

GSK Investigational Site, Denver, Colorado 80206, United States

GSK Investigational Site, Denver, Colorado 80230, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, Coral Gables, Florida 33134, United States

GSK Investigational Site, Miami, Florida 33176, United States

GSK Investigational Site, Sarasota, Florida 34239, United States

GSK Investigational Site, Tampa, Florida 33613, United States

GSK Investigational Site, Lawrenceville, Georgia 30045, United States

GSK Investigational Site, Lilburn, Georgia 30047, United States

GSK Investigational Site, Marietta, Georgia 30060, United States

GSK Investigational Site, Kenilworth, Illinois 60043, United States

GSK Investigational Site, Iowa City, Iowa 52242, United States

GSK Investigational Site, Covington, Louisiana 70433, United States

GSK Investigational Site, Lafayette, Louisiana 70503, United States

GSK Investigational Site, Metairie, Louisiana 70006, United States

GSK Investigational Site, Baltimore, Maryland 21236, United States

GSK Investigational Site, Bethesda, Maryland 20814, United States

GSK Investigational Site, Chevy Chase, Maryland 20815, United States

GSK Investigational Site, North Andover, Massachusetts 01845, United States

GSK Investigational Site, Ypsilanti, Michigan 48197, United States

GSK Investigational Site, Rolla, Missouri 65401, United States

GSK Investigational Site, Omaha, Nebraska 68130, United States

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

GSK Investigational Site, Skillman, New Jersey 08558, United States

GSK Investigational Site, Ithaca, New York 14850, United States

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

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

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, North Olmsted, Ohio 44070, United States

GSK Investigational Site, Sylvania, Ohio 43560, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73104, United States

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

GSK Investigational Site, Eugene, Oregon 97401, United States

GSK Investigational Site, Lake Oswego, Oregon 97035, United States

GSK Investigational Site, Medford, Oregon 97504, United States

GSK Investigational Site, Collegeville, Pennsylvania 19426, United States

GSK Investigational Site, Gibsonia, Pennsylvania 15044, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19115, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, East Providence, Rhode Island 02914, United States

GSK Investigational Site, Providence, Rhode Island 02906, United States

GSK Investigational Site, Charleston, South Carolina 29406, United States

GSK Investigational Site, Charleston, South Carolina 29414, United States

GSK Investigational Site, Greer, South Carolina 29651, United States

GSK Investigational Site, Chattanooga, Tennessee 37421, United States

GSK Investigational Site, Germantown, Tennessee 38138, United States

GSK Investigational Site, Austin, Texas 78704, United States

GSK Investigational Site, Austin, Texas 78750, United States

GSK Investigational Site, Corsicana, Texas 75110, United States

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Dallas, Texas 75231-4307, United States

GSK Investigational Site, Dallas, Texas 75231, United States

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

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

GSK Investigational Site, Houston, Texas 77054, United States

GSK Investigational Site, Houston, Texas 77070, United States

GSK Investigational Site, Killeen, Texas 76542, United States

GSK Investigational Site, Plano, Texas 75093, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

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

GSK Investigational Site, Waco, Texas 76712, United States

GSK Investigational Site, Murray, Utah 84107, United States

GSK Investigational Site, West Jordan, Utah 84084, United States

GSK Investigational Site, South Burlington, Vermont 05403, United States

GSK Investigational Site, Charlottesville, Virginia 22908, United States

Additional Information

Starting date: September 2005
Last updated: September 5, 2013

Page last updated: August 23, 2015

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