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

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	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:	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)

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

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
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	12 Years and older
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 Clinical Trials Call Center
Chicago, Illinois, United States, 60637
United States, Indiana
GSK Clinical Trials Call Center
Indianapolis, Indiana, United States, 46208
GSK Clinical Trials Call Center
Lafayette, Indiana, United States, 47904
United States, Kentucky
GSK Clinical Trials Call Center
Louisville, Kentucky, United States, 40215
United States, Michigan
GSK Clinical Trials Call Center
Novi, Michigan, United States, 48375
United States, Minnesota
GSK Clinical Trials Call Center
Minneapolis, Minnesota, United States, 55402
United States, Missouri
GSK Clinical Trials Call Center
Columbia, Missouri, United States, 65203
GSK Clinical Trials Call Center
Rolla, Missouri, United States, 65401
GSK Clinical Trials Call Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
GSK Clinical Trials Call Center
Lincoln, Nebraska, United States, 68505
GSK Clinical Trials Call Center
Papillion, Nebraska, United States, 68046
United States, Ohio
GSK Clinical Trials Call Center
Canton, Ohio, United States, 44718
GSK Clinical Trials Call Center
Sylvania, Ohio, United States, 43560
United States, Oklahoma
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States, 73134
United States, South Carolina
GSK Clinical Trials Call Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75231
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75230
United States, Wisconsin
GSK Clinical Trials Call Center
Greenfield, Wisconsin, United States, 53228
GSK Clinical Trials Call Center
West Allis, Wisconsin, United States, 53227

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trial, MD	GlaxoSmithKline

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00197262 History of Changes
Other Study ID Numbers:	FFR104861
Study First Received:	September 15, 2005
Last Updated:	October 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


Seasonal Allergic Rhinitis allergic rhinitis GW685698X Hayfever

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic, Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases	Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 27, 2015