Study Of Patients With Allergic Rhinitis And Asthma
Overview[ - collapse ][ - ]
| 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 | Asthma |
| Intervention | Drug: fluticasone propionate/salmeterol Drug: fluticasone propionate Drug: montelukast |
| Phase | Phase 4 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00296530 |
| First Received | February 23, 2006 |
| Last Updated | September 5, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 23, 2006 |
|---|---|
| Last Updated Date | September 5, 2013 |
| Start Date | September 2005 |
| Estimated Primary Completion Date | July 2007 |
| Current Primary Outcome Measures | Morning Peak Expiratory Flow |
| Current Secondary Outcome Measures | Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study Of Patients With Allergic Rhinitis And Asthma |
|---|---|
| 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 |
| 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. |
| 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 |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: fluticasone propionate/salmeterol Drug: fluticasone propionate Drug: montelukast Other Names:
|
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 600 |
| Estimated Completion Date | July 2007 |
| Estimated Primary Completion Date | July 2007 |
| Eligibility 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. |
| Gender | Both |
| Ages | 15 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00296530 |
|---|---|
| Other Study ID Numbers | ADA103578 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| GSK Investigational Site | Ozark, Alabama, United States, 36360 |
|---|---|
| GSK Investigational Site | Tempe, Arizona, United States, 85282 |
| GSK Investigational Site | Little Rock, Arkansas, United States, 72205 |
| 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 |
| GSK Investigational Site | Colorado Springs, Colorado, United States, 80907 |
| GSK Investigational Site | Denver, Colorado, United States, 80230 |
| GSK Investigational Site | Denver, Colorado, United States, 80206 |
| GSK Investigational Site | Wheat Ridge, Colorado, United States, 80033 |
| GSK Investigational Site | Coral Gables, Florida, United States, 33134 |
| GSK Investigational Site | Miami, Florida, United States, 33176 |
| GSK Investigational Site | Sarasota, Florida, United States, 34239 |
| GSK Investigational Site | Tampa, Florida, United States, 33613 |
| GSK Investigational Site | Lawrenceville, Georgia, United States, 30045 |
| GSK Investigational Site | Lilburn, Georgia, United States, 30047 |
| GSK Investigational Site | Marietta, Georgia, United States, 30060 |
| GSK Investigational Site | Kenilworth, Illinois, United States, 60043 |
| GSK Investigational Site | Iowa City, Iowa, United States, 52242 |
| GSK Investigational Site | Covington, Louisiana, United States, 70433 |
| GSK Investigational Site | Lafayette, Louisiana, United States, 70503 |
| GSK Investigational Site | Metairie, Louisiana, United States, 70006 |
| 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 |
| GSK Investigational Site | North Andover, Massachusetts, United States, 01845 |
| GSK Investigational Site | Ypsilanti, Michigan, United States, 48197 |
| GSK Investigational Site | Rolla, Missouri, United States, 65401 |
| GSK Investigational Site | Omaha, Nebraska, United States, 68130 |
| GSK Investigational Site | Ocean, New Jersey, United States, 07712 |
| GSK Investigational Site | Skillman, New Jersey, United States, 08558 |
| GSK Investigational Site | Ithaca, New York, United States, 14850 |
| GSK Investigational Site | Charlotte, North Carolina, United States, 28204 |
| GSK Investigational Site | Winston-Salem, North Carolina, United States, 27103 |
| GSK Investigational Site | Cincinnati, Ohio, United States, 45231 |
| GSK Investigational Site | North Olmsted, Ohio, United States, 44070 |
| GSK Investigational Site | Sylvania, Ohio, United States, 43560 |
| GSK Investigational Site | Oklahoma City, Oklahoma, United States, 73120 |
| GSK Investigational Site | Oklahoma City, Oklahoma, United States, 73104 |
| GSK Investigational Site | Eugene, Oregon, United States, 97401 |
| GSK Investigational Site | Lake Oswego, Oregon, United States, 97035 |
| GSK Investigational Site | Medford, Oregon, United States, 97504 |
| GSK Investigational Site | Collegeville, Pennsylvania, United States, 19426 |
| GSK Investigational Site | Gibsonia, Pennsylvania, United States, 15044 |
| GSK Investigational Site | Philadelphia, Pennsylvania, United States, 19115 |
| GSK Investigational Site | Philadelphia, Pennsylvania, United States, 19140 |
| GSK Investigational Site | East Providence, Rhode Island, United States, 02914 |
| GSK Investigational Site | Providence, Rhode Island, United States, 02906 |
| 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 |
| GSK Investigational Site | Chattanooga, Tennessee, United States, 37421 |
| GSK Investigational Site | Germantown, Tennessee, United States, 38138 |
| 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, 75231-4307 |
| GSK Investigational Site | Dallas, Texas, United States, 75231 |
| GSK Investigational Site | Dallas, Texas, United States, 75230 |
| GSK Investigational Site | El Paso, Texas, United States, 79902 |
| GSK Investigational Site | El Paso, Texas, United States, 79925 |
| GSK Investigational Site | Houston, Texas, United States, 77054 |
| GSK Investigational Site | Houston, Texas, United States, 77070 |
| 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 |
| GSK Investigational Site | Murray, Utah, United States, 84107 |
| GSK Investigational Site | West Jordan, Utah, United States, 84084 |
| GSK Investigational Site | South Burlington, Vermont, United States, 05403 |
| GSK Investigational Site | Charlottesville, Virginia, United States, 22908 |