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Completed

NCT Number: NCT00363740

Study of GW685698X In Patients With Seasonal Allergic Rhinitis

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent
  • Outpatient
  • Diagnosis of seasonal allergic rhinitis with symptoms
  • Able to comply with study procedures

Exclusion criteria

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

Treatment and study plan

GW685698X Aqueous Nasal Spray

Drug

Primary outcomes

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

Secondary outcomes

  1. Mean change from baseline over the entire treatment period in four total nasal symptom scores.

  2. Mean change from baseline over the entire treatment period in individual total nasal symptom scores.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 Over Fluticasone Propionate Using a Double-blind Manner-

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 15, 2006
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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