Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100mcg in Adolescent and Adult Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118729
• Other study ID #: FFR101816
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2005
• Last updated: September 13, 2016
• Start date: April 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 purpose of this study is to evaluate the onset of action of an investigational nasal spray, GW685698X aqueous nasal spray, versus vehicle placebo nasal spray in the treatment of seasonal allergic rhinitis caused by ragweed following a single dose of treatment in controlled pollen concentrations in an allergen challenge chamber.

Description:

Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100 mcg in Adolescent and Adult Subjects (=12 years of age) With Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion criteria:

• Informed consent

• Outpatient

• Females must use appropriate contraception

• Diagnosis of seasonal allergic rhinitis

• Able to comply with study procedures

• Literate

Exclusion criteria:

• Significant concomitant medical condition

• Use of corticosteroids, allergy medications, or tobacco

• Clinically significant abnormal ECG

• Laboratory abnormality

• Positive pregnancy test

• Allergy to any component of investigational product

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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	Woodstock	Georgia

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 in subject-rated total nasal symptom score following a single dose of GW685698X aqueous nasal spray during exposure to ragweed pollen over a 12-hour period.
Secondary	Change from baseline in the individual nasal symptom scores of rhinorrhea, nasal congestion, nasal itching and sneezing, assessed hourly during the 12-hour, post-dose exposure period to ragweed pollen in the allergen challenge chamber.

External Links

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