Last updated: 11/07/2018 16:48:14
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 4 week randomized, double blind, placebo controlled study of GW685698X Aq nasal spray 100mcg QD in adults and adolescents with Vasomotor Rhinitis
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline in daily reflective total nasal symptom scores (rTNSS)
Timeframe: Baseline and up to Week 4
Secondary outcomes:
Mean change from Baseline in morning (AM) pre-dose instantaneous total nasal symptom scores (iTNSS)
Timeframe: Baseline and up to Week 4
Number of participants based on overall evaluation of response to therapy
Timeframe: Week 4 (Day 29) or Early Withdrawal
Interventions:
Enrollment:
350
Primary completion date:
2006-09-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jacobs R, Lieberman P, Kent E, Silvey MJ, Locantore N, Philpot EE. Weather/temperature-sensitive vasomotor rhinitis may be refractory to intranasal corticosteroid treatment. Allergy Asthma Proc. 2009;30(2):120-7.
Medical condition
Vasomotor Rhinitis, Rhinitis, Vasomotor
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
July 2005 to February 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Must be outpatients.
- Diagnosis of VMR (vasomotor rhinitis).
- Significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Vero Beach, Florida, United States, 32960
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ithaca, New York, United States, 14850
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95128
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60632
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Study Complete
Location
GSK Investigational Site
Paramount, California, United States, 90723
Status
Study Complete
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 8724
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Study Complete
Location
GSK Investigational Site
Blue Belle, Pennsylvania, United States, 19422
Status
Study Complete
Location
GSK Investigational Site
Sarasota, Florida, United States, 34233
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85012
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94102
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 2906
Status
Study Complete
Location
GSK Investigational Site
Ponce, Puerto Rico, Puerto Rico, 00716
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-09-02
Actual study completion date
2006-09-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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