Study Of Patients With Allergic Rhinitis And Asthma
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
1 other identifier
interventional
600
1 country
80
Brief 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.
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 Sep 2005
80 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
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedOctober 28, 2016
October 1, 2016
1.8 years
February 23, 2006
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morning Peak Expiratory Flow
Secondary Outcomes (1)
Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (80)
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 City, 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, 78205, United States
GSK Investigational Site
San Antonio, Texas, 78229, 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
Related Publications (2)
This study has not been published in the scientific literature.
BACKGROUNDKatial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan-Feb;31(1):68-75. doi: 10.2500/aap.2010.31.3306.
PMID: 20167147DERIVED
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 23, 2006
First Posted
February 27, 2006
Study Start
September 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
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.