Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00118703
First received: July 1, 2005
Last updated: June 21, 2012
Last verified: March 2011
  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 vasomotor rhinitis (VMR).


Condition Intervention Phase
Vasomotor Rhinitis
Rhinitis, Vasomotor
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: 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 Vasomotor Rhinitis

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 VMR (vasomotor rhinitis) 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 this overall evaluation of response to therapy during the last clinic visit.

Estimated Enrollment: 350
Study Start Date: July 2005
Intervention Details:
    Drug: GW685698X
    Other Name: GW685698X
  Eligibility

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

Inclusion criteria:

  • Must be outpatients.
  • Diagnosis of VMR (vasomotor rhinitis).
  • Literate in English or native language.

Exclusion criteria:

  • Significant concomitant medical condition.
  • Use corticosteroids or other allergy medications during the study.
  • Used tobacco products within the past year.
  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: NCT00118703

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35209
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Sacramento, California, United States, 95819
GSK Investigational Site
San Francisco, California, United States, 94102
GSK Investigational Site
San Jose, California, United States, 95128
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
GSK Investigational Site
Englewood, Colorado, United States, 80112
United States, Florida
GSK Investigational Site
Sarasota, Florida, United States, 34233
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Vero Beach, Florida, United States, 32960
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60632
United States, Indiana
GSK Investigational Site
South Bend, Indiana, United States, 46617
United States, Maryland
GSK Investigational Site
Wheaton, Maryland, United States, 20902
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Brick, New Jersey, United States, 8724
GSK Investigational Site
Skillman, New Jersey, United States, 08558
United States, New York
GSK Investigational Site
Ithaca, New York, United States, 14850
GSK Investigational Site
Rochester, New York, United States, 14618
United States, Pennsylvania
GSK Investigational Site
Blue Belle, Pennsylvania, United States, 19422
United States, Tennessee
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Canada, Quebec
GSK Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 656 51
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Plzen, Czech Republic, 301 00
GSK Investigational Site
Praha 5, Czech Republic, 150 06
Germany
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Nuernberg, Bayern, Germany, 90443
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Berlin, Germany, 14057
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 12163
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00716
Romania
GSK Investigational Site
Bucharest, Romania, 022102
GSK Investigational Site
Iasi, Romania, 700115
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00118703     History of Changes
Other Study ID Numbers: FFR30007
Study First Received: July 1, 2005
Last Updated: June 21, 2012
Health Authority: European Union: European Medicines Agency
Norway: Norwegian Medicines Agency
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
nonallergic rhinitis
vasomotor rhinitis
GW685698X
VMR

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Vasomotor
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 30, 2014