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Completed

NCT Number: NCT00115622

Study In Adults And Adolescents With Seasonal Allergic Rhinitis

The purpose of the study is to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray 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. Commonly referred to as "hay fever", it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Austin, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent.
  • Outpatient.
  • Females must use appropriate contraception.
  • Diagnosis of seasonal allergic rhinitis.
  • Adequate exposure to allergen.
  • 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 the investigational product.

Treatment and study plan

Fluticasone Furoate

Drug

Primary outcomes

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

  2. Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score.

Secondary outcomes

  1. Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 Days in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 24, 2005
Registry last updated
Sep 1, 2016

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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