Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00197262 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : January 19, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rhinitis, Allergic, Seasonal | Drug: GW685698X Aqueous Nasal Spray | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 288 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Single-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 mcg for 2 Weeks in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis |
Study Start Date : | August 2005 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |
- Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.
- 1) Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. 2) Mean change from baseline in daily reflective total ocular symptom scores. 3) overall evaluation of response to therapy.

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Must be outpatients.
- Diagnosis of SAR.
- Literate in English or native language.
Exclusion criteria:
- Have a significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Use tobacco products.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197262
United States, Illinois | |
GSK Investigational Site | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
GSK Investigational Site | |
Indianapolis, Indiana, United States, 46208 | |
GSK Investigational Site | |
Lafayette, Indiana, United States, 47904 | |
United States, Kentucky | |
GSK Investigational Site | |
Louisville, Kentucky, United States, 40215 | |
United States, Michigan | |
GSK Investigational Site | |
Novi, Michigan, United States, 48375 | |
United States, Minnesota | |
GSK Investigational Site | |
Minneapolis, Minnesota, United States, 55402 | |
United States, Missouri | |
GSK Investigational Site | |
Columbia, Missouri, United States, 65203 | |
GSK Investigational Site | |
Rolla, Missouri, United States, 65401 | |
GSK Investigational Site | |
St. Louis, Missouri, United States, 63141 | |
United States, Nebraska | |
GSK Investigational Site | |
Lincoln, Nebraska, United States, 68505 | |
GSK Investigational Site | |
Papillion, Nebraska, United States, 68046 | |
United States, Ohio | |
GSK Investigational Site | |
Canton, Ohio, United States, 44718 | |
GSK Investigational Site | |
Sylvania, Ohio, United States, 43560 | |
United States, South Carolina | |
GSK Investigational Site | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Texas | |
GSK Investigational Site | |
Dallas, Texas, United States, 75231-4307 | |
GSK Investigational Site | |
Dallas, Texas, United States, 75231 | |
United States, Wisconsin | |
GSK Investigational Site | |
Greenfield, Wisconsin, United States, 53228 | |
GSK Investigational Site | |
West Allis, Wisconsin, United States, 53227 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197262 |
Other Study ID Numbers: |
FFR104861 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | January 19, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Seasonal Allergic Rhinitis GW685698X allergic rhinitis Hayfever |
Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Respiratory Tract Infections Infections Nose Diseases |
Respiratory Tract Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |