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

Rhinitis, Allergic, Seasonal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197262
• Other study ID #: FFR104861
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: January 18, 2017
• Start date: August 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• GW685698X Aqueous Nasal Spray

Locations

Country	Name	City	State
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Greenfield	Wisconsin
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lafayette	Indiana
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Novi	Michigan
United States	GSK Investigational Site	Papillion	Nebraska
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Sylvania	Ohio
United States	GSK Investigational Site	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.
Secondary	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.

External Links

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