Study of GW685698X In Patients With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363740
First received: August 11, 2006
Last updated: April 11, 2013
Last verified: May 2012
  Purpose

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 Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: GW685698X Aqueous Nasal Spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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-

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 38
Study Start Date: February 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW685698X Aqueous Nasal Spray
    Other Name: GW685698X Aqueous Nasal Spray
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363740

Locations
Spain
GSK Investigational Site
Unknown, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363740     History of Changes
Other Study ID Numbers: FFR100652
Study First Received: August 11, 2006
Last Updated: April 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
GW685698X
allergic rhinitis
Seasonal Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 28, 2014