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

NCT00118729 | Completed Phase 3

• 1 other identifier: FFR101816
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Ragweed; GW685698X; seasonal allergic rhinitis; onset

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: GW685698X Aqueous Nasal Spray

Interventions

GW685698X Aqueous Nasal Spray DRUG

Arm 1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Outpatient
• Females must use appropriate contraception
• Diagnosis of seasonal allergic rhinitis
• Able to comply with study procedures
• Literate

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Woodstock, Georgia, 30188, United States

Location

Related Links

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MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: April 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)