Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis
1 other identifier
interventional
350
7 countries
59
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2005
Shorter than P25 for phase_3
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2005
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2006
CompletedResults Posted
Study results publicly available
May 2, 2017
CompletedAugust 21, 2017
March 1, 2017
7 months
July 1, 2005
March 21, 2017
July 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \[PM\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.
Baseline and up to Week 4
Secondary Outcomes (2)
Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)
Baseline and up to Week 4
Number of Participants Based on Overall Evaluation of Response to Therapy
Week 4 (Day 29) or Early Withdrawal
Interventions
Eligibility Criteria
You may qualify if:
- Must be outpatients.
- Diagnosis of VMR (vasomotor rhinitis).
- Literate in English or native language.
You may not qualify if:
- Significant concomitant medical condition.
- Use corticosteroids or other allergy medications during the study.
- Used tobacco products within the past year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (59)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Sacramento, California, 95819, United States
GSK Investigational Site
San Francisco, California, 94102, United States
GSK Investigational Site
San Jose, California, 95128, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Sarasota, Florida, 34233, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Vero Beach, Florida, 32960, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Chicago, Illinois, 60632, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Shreveport, Louisiana, 71105, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Wheaton, Maryland, 20902, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Brick, New Jersey, 8724, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Rochester, New York, 14618, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Blue Bell, Pennsylvania, 19422, United States
GSK Investigational Site
Providence, Rhode Island, 2906, United States
GSK Investigational Site
Chattanooga, Tennessee, 37421, United States
GSK Investigational Site
Dallas, Texas, 75231-4307, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2, Canada
GSK Investigational Site
Hamilton, Ontario, L8M 1K7, Canada
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Brno, 656 51, Czechia
GSK Investigational Site
Pardubice, 532 03, Czechia
GSK Investigational Site
Pilsen, 301 00, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90443, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65187, Germany
GSK Investigational Site
Berlin, 12163, Germany
GSK Investigational Site
Berlin, 13125, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Oslo, N-0264, Norway
GSK Investigational Site
Oslo, N-0594, Norway
GSK Investigational Site
Ponce, 00716, Puerto Rico
GSK Investigational Site
Bucharest, 022102, Romania
GSK Investigational Site
Iași, 700115, Romania
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2005
First Posted
July 12, 2005
Study Start
July 1, 2005
Primary Completion
February 1, 2006
Study Completion
February 9, 2006
Last Updated
August 21, 2017
Results First Posted
May 2, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.