Study of GW685698X In Patients With Seasonal Allergic Rhinitis

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Seasonal

• Registration Number: NCT00363740
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug in the treatment of seasonal allergic rhinitis. 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-19
• Primary Completion: 2005-04-01
• Study Completion: 2005-04-13
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

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Exclusion Criteria

• Significant concomitant medical condition
• Use of corticosteroids/allergy medications
• Laboratory abnormality
• Positive pregnancy test
• Allergy to any component of investigational product

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change from baseline over the entire treatment period in three total nasal symptom scores.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline over the entire treatment period in four total nasal symptom scores.
Mean change from baseline over the entire treatment period in individual total nasal symptom scores.

Trial Locations

Locations (1)

GSK Investigational Site