Last updated: 11/07/2018 16:47:47
Study Of Adults And Adolescents With Vasomotor Rhinitis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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:
Not applicable
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline over the entire treatment period in daily reflective total nasal symptom score (rTNSS)
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary outcomes:
Mean change from baseline over the entire treatment period in morning (AM), pre-dose, instantaneous total nasal symptom scores (iTNSS)
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Number of participants with overall evaluation of response to therapy
Timeframe: Up to 4 weeks
Mean change from baseline over the entire treatment period in AM pre-dose rTNSS
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean change from baseline over the entire treatment period in evening (PM) rTNSS
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean percent change from Baseline over the entire treatment period in daily rTNSS
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean percent change from baseline over the entire treatment period in AM, pre-dose iTNSS
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean change from baseline over the entire treatment period in individual daily, reflective nasal symptom scores for rhinorrhea, nasal congestion and post-nasal drip
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean change from baseline over the entire treatment period in individual AM, pre-dose, instantaneous, nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean change from baseline over the entire treatment period in individual AM, reflective nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean change from baseline over the entire treatment period in individual PM, reflective, nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip
Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Mean Scores Changes from Baseline as a Function of Time
Timeframe: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days
Interventions:
Drug: GW685698X
Enrollment:
352
Observational study model:
Not applicable
Primary completion date:
2006-09-02
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
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.
- 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.
- 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
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 9L8
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Mount Laurel, New Jersey, United States, 08054
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Santa Barbara, California, United States, 93105
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20850
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40207
Status
Study Complete
Location
GSK Investigational Site
Easton, Pennsylvania, United States, 18042
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71104
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
North Olmsted, Ohio, United States, 44070
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30188
Status
Study Complete
Location
GSK Investigational Site
Liverpool, New York, United States, 13088
Status
Study Complete
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80526
Status
Study Complete
Location
GSK Investigational Site
Palmyra, Pennsylvania, United States, 17078
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90212
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84102
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
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
Completed
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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