A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00103454
First received: February 8, 2005
Last updated: January 22, 2009
Last verified: January 2009
  Purpose

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: GW685698X
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.

Secondary Outcome Measures:
  • Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.

Estimated Enrollment: 288
Study Start Date: January 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW685698X
    Other Name: GW685698X
Detailed Description:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of perennial allergic rhinitis (PAR).
  • Must comply with study procedures and be literate.

Exclusion criteria:

  • Significant concomitant medical conditions.
  • Use of corticosteroids.
  • Use of allergy medications and some other medications during the study.
  • Current tobacco use.
  • Clinically significant abnormal ECG or laboratory abnormality.
  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: NCT00103454

  Hide Study Locations
Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Mission Viejo, California, United States, 92691
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
San Diego, California, United States, 92120
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33176
GSK Investigational Site
Miami, Florida, United States, 33173
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Tampa, Florida, United States, 33613
GSK Investigational Site
Vero Beach, Florida, United States, 32960
United States, Georgia
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Lilburn, Georgia, United States, 30047
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46617
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maine
GSK Investigational Site
Portland, Maine, United States, 04102
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Rockville, Maryland, United States, 20850
United States, Massachusetts
GSK Investigational Site
North Andover, Massachusetts, United States, 01845
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
St. Louis, Missouri, United States, 63104
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
GSK Investigational Site
Omaha, Nebraska, United States, 68130
United States, New Jersey
GSK Investigational Site
Ocean, New Jersey, United States, 07712
GSK Investigational Site
Summit, New Jersey, United States, 07091
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78731
GSK Investigational Site
New Braunfels, Texas, United States, 78130
United States, Utah
GSK Investigational Site
Murray, Utah, United States, 84107
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Canada, British Columbia
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 9L8
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L5A 1N1
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
Canada, Quebec
GSK Investigational Site
Québec, Quebec, Canada, G1V 4M6
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7H 0V1
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00103454     History of Changes
Other Study ID Numbers: FFR30002
Study First Received: February 8, 2005
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Perennial Allergic Rhinitis
allergic rhinitis
GW685698X

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

ClinicalTrials.gov processed this record on September 18, 2014