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Study Of Patients With Allergic Rhinitis And Asthma

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00296530
First received: February 23, 2006
Last updated: May 15, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
Allergic Rhinitis
 Drug: fluticasone propionate/salmeterol
Drug: fluticasone propionate
Drug: montelukast
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Morning Peak Expiratory Flow

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

Estimated Enrollment: 600
Study Start Date: September 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluticasone propionate/salmeterol Drug: fluticasone propionate Drug: montelukast
    Other Names:
    • fluticasone propionate/salmeterol
    • fluticasone propionate
    • montelukast
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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296530

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Ozark, Alabama, United States, 36360
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Los Angeles, California, United States, 90095-1752
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
Palmdale, California, United States, 93551
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
San Jose, California, United States, 95128
GSK Investigational Site
Stockton, California, United States, 95207
GSK Investigational Site
Vista, California, United States, 92083
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Denver, Colorado, United States, 80206
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Miami, Florida, United States, 33176
GSK Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Lilburn, Georgia, United States, 30047
GSK Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
GSK Investigational Site
Kenilworth, Illinois, United States, 60043
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Louisiana
GSK Investigational Site
Covington, Louisiana, United States, 70433
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Bethesda, Maryland, United States, 20814
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
GSK Investigational Site
North Andover, Massachusetts, United States, 01845
United States, Michigan
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Missouri
GSK Investigational Site
Rolla, Missouri, United States, 65401
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68130
United States, New Jersey
GSK Investigational Site
Ocean, New Jersey, United States, 07712
GSK Investigational Site
Skillman, New Jersey, United States, 08558
United States, New York
GSK Investigational Site
Ithaca, New York, United States, 14850
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
GSK Investigational Site
Sylvania, Ohio, United States, 43560
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Collegeville, Pennsylvania, United States, 19426
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29414
GSK Investigational Site
Charleston, South Carolina, United States, 29406
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
GSK Investigational Site
Germantown, Tennessee, United States, 38138
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78704
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
Corsicana, Texas, United States, 75110
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
GSK Investigational Site
El Paso, Texas, United States, 79925
GSK Investigational Site
El Paso, Texas, United States, 79902
GSK Investigational Site
Houston, Texas, United States, 77070
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
Killeen, Texas, United States, 76542
GSK Investigational Site
Plano, Texas, United States, 75093
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
Waco, Texas, United States, 76712
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84107
GSK Investigational Site
West Jordan, Utah, United States, 84084
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00296530     History of Changes
Other Study ID Numbers: ADA103578
Study First Received: February 23, 2006
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Asthma
Allergic Rhinitis

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Salmeterol
Fluticasone
 Montelukast
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013