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Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197262
First received: September 15, 2005
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: GW685698X Aqueous Nasal Spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 288
Study Start Date: August 2005
Study Completion Date: October 2005
Detailed Description:
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 2 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Seasonal Allergic Rhinitis (SAR)
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197262

Locations
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197262     History of Changes
Other Study ID Numbers: FFR104861 
Study First Received: September 15, 2005
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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.

Keywords provided by GlaxoSmithKline:
Seasonal Allergic Rhinitis
GW685698X
allergic rhinitis
Hayfever

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016