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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/salmeterol | Drug | |||
| fluticasone propionate | Drug | |||
| montelukast | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morning Peak Expiratory Flow |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days |
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Inclusion Criteria:
Exclusion Criteria:
The study doctor will evaluate other inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ozark | Alabama | 36360 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. | ||
| 20167147 | Derived | Katial 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| ADA103578 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| ADA103578 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ADA103578 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ADA103578 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ADA103578 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ADA103578 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ADA103578 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068298 | Fluticasone |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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