Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00118703
First received: July 1, 2005
Last updated: June 21, 2012
Last verified: March 2011
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118703
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| 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, 12163 | |
| GSK Investigational Site | |
| Berlin, Germany, 13125 | |
| GSK Investigational Site | |
| Berlin, Germany, 14057 | |
| 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 |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013