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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Rhinitis, Allergic, Seasonal	Drug: GW685698X Aqueous Nasal Spray	Phase 3

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)

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Primary Outcome Measures :

1. Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.

Secondary Outcome Measures :

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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Clinical Study Report 

Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: FFR104861
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

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
First Posted:	September 20, 2005
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.

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