Rhinitis, Allergic, Perennial Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)
| Verified date | September 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.
| Status | Completed |
| Enrollment | 576 |
| Est. completion date | November 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 12 Years |
| Eligibility |
Inclusion criteria: - Diagnosis of seasonal allergic rhinitis. - Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area. Exclusion criteria: - Have significant concomitant medical conditions. - Use of corticosteroids, other allergy meds during the study. - Have abnormal ECG or laboratory abnormality. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Altoona | Pennsylvania |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bethesda | Maryland |
| United States | GSK Investigational Site | Brockton | Massachusetts |
| United States | GSK Investigational Site | Canton | Ohio |
| United States | GSK Investigational Site | Centennial | Colorado |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Costa Mesa | California |
| United States | GSK Investigational Site | Cranberry Township | Pennsylvania |
| United States | GSK Investigational Site | Cudahy | California |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | Englewood | Colorado |
| United States | GSK Investigational Site | Fort Collins | Colorado |
| United States | GSK Investigational Site | Gainesville | Georgia |
| United States | GSK Investigational Site | Greenfield | Wisconsin |
| United States | GSK Investigational Site | Hackensack | New Jersey |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Ithaca | New York |
| United States | GSK Investigational Site | Jackson | Mississippi |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Lake Oswego | Oregon |
| United States | GSK Investigational Site | Lakewood | Colorado |
| United States | GSK Investigational Site | Lawrenceville | Georgia |
| United States | GSK Investigational Site | Lilburn | Georgia |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Madison | Wisconsin |
| United States | GSK Investigational Site | Metairie | Louisiana |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Mineola | New York |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | North Andover | Massachusetts |
| United States | GSK Investigational Site | North Dartmouth | Massachusetts |
| United States | GSK Investigational Site | Ocean | New Jersey |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orange | California |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Richland | Michigan |
| United States | GSK Investigational Site | Riverside | California |
| United States | GSK Investigational Site | Rolla | Missouri |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Springfield | Massachusetts |
| United States | GSK Investigational Site | Stockbridge | Georgia |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Topeka | Kansas |
| United States | GSK Investigational Site | Utica | New York |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Warrensburg | Missouri |
| United States | GSK Investigational Site | Woodstock | Georgia |
| United States | GSK Investigational Site | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years. | |||
| Secondary | Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years. |
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