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 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Status | Completed |
Enrollment | 288 |
Est. completion date | May 2005 |
Est. primary completion date | May 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion criteria: - Diagnosis of perennial allergic rhinitis (PAR). - Must comply with study procedures and be literate. Exclusion criteria: - Significant concomitant medical conditions. - Use of corticosteroids. - Use of allergy medications and some other medications during the study. - Current tobacco use. - Clinically significant abnormal ECG or laboratory abnormality. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | GSK Investigational Site | Kelowna | British Columbia |
Canada | GSK Investigational Site | Mississauga | Ontario |
Canada | GSK Investigational Site | Ottawa | Ontario |
Canada | GSK Investigational Site | Québec | Quebec |
Canada | GSK Investigational Site | Saskatoon | Saskatchewan |
Canada | GSK Investigational Site | Vancouver | British Columbia |
United States | GSK Investigational Site | Austin | Texas |
United States | GSK Investigational Site | Baltimore | Maryland |
United States | GSK Investigational Site | Canton | Ohio |
United States | GSK Investigational Site | Cincinnati | Ohio |
United States | GSK Investigational Site | Colorado Springs | Colorado |
United States | GSK Investigational Site | Eugene | Oregon |
United States | GSK Investigational Site | Lake Oswego | Oregon |
United States | GSK Investigational Site | Lawrenceville | Georgia |
United States | GSK Investigational Site | Lilburn | Georgia |
United States | GSK Investigational Site | Lincoln | Nebraska |
United States | GSK Investigational Site | Little Rock | Arkansas |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Medford | Oregon |
United States | GSK Investigational Site | Metairie | Louisiana |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Mission Viejo | California |
United States | GSK Investigational Site | Murray | Utah |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | New Braunfels | Texas |
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 | Orangeburg | South Carolina |
United States | GSK Investigational Site | Portland | Maine |
United States | GSK Investigational Site | Providence | Rhode Island |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Rockville | Maryland |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | San Diego | California |
United States | GSK Investigational Site | South Bend | Indiana |
United States | GSK Investigational Site | South Burlington | Vermont |
United States | GSK Investigational Site | Springfield | Massachusetts |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | St. Louis | Missouri |
United States | GSK Investigational Site | Summit | New Jersey |
United States | GSK Investigational Site | Tallahassee | Florida |
United States | GSK Investigational Site | Tampa | Florida |
United States | GSK Investigational Site | Vero Beach | Florida |
United States | GSK Investigational Site | West Allis | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Canada,
Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms. | |||
Secondary | Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit. |
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