Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)
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
1 other identifier
interventional
288
1 country
18
Brief Summary
Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as (hay fever), it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. 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 seasonal allergic rhinitis (SAR) caused by ragweed pollen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2005
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedJanuary 19, 2017
January 1, 2017
2 months
September 15, 2005
January 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Must be outpatients.
- Diagnosis of SAR.
- Literate in English or native language.
You may not qualify if:
- Have a significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Use tobacco products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (18)
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
Louisville, Kentucky, 40215, United States
GSK Investigational Site
Novi, Michigan, 48375, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Columbia, Missouri, 65203, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Lincoln, Nebraska, 68505, United States
GSK Investigational Site
Papillion, Nebraska, 68046, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Dallas, Texas, 75231-4307, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
West Allis, Wisconsin, 53227, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 20, 2005
Study Start
August 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
January 19, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.