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Study of GW685698X In Patients With Seasonal Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00363740
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : April 15, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: GW685698X Aqueous Nasal Spray Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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-
Study Start Date : February 2005
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

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

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363740

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363740     History of Changes
Other Study ID Numbers: FFR100652
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: May 2012

Keywords provided by GlaxoSmithKline:
allergic rhinitis
Seasonal Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases