Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
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 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)
1 other identifier
interventional
301
9 countries
42
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 perennial allergic rhinitis (PAR).
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 Feb 2006
Shorter than P25 for phase_3
42 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
Study Start
First participant enrolled
February 7, 2006
CompletedFirst Submitted
Initial submission to the registry
February 8, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2006
CompletedResults Posted
Study results publicly available
April 13, 2018
CompletedApril 13, 2018
September 1, 2017
5 months
February 8, 2006
April 17, 2017
September 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received \>=1 dose of study drug. Only those participants available at the specified time points were analyzed
Baseline (Day 1) and up to Week 6
Secondary Outcomes (21)
Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period
Baseline (Day 1) and up to Week 6
Number of Participants With Response to Therapy Over Entire Treatment Period
Up to 6 weeks
Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period
Baseline (Day 1) and up to 6 weeks
Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period
Baseline (Day 1) and up to 6 weeks
Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period
Baseline (Day 1) and up to 6 weeks
- +16 more secondary outcomes
Study Arms (2)
Fluticasone furoate
EXPERIMENTALParticipants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg
Placebo
PLACEBO COMPARATORParticipants were instructed to administer two sprays into each nostril once daily every morning of placebo
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of perennial allergic rhinitis (PAR).
- Must comply with study procedures and be literate.
You may not qualify if:
- Significant concomitant medical conditions.
- Use of corticosteroids.
- Use of allergy and other identified medications during the study.
- Current tobacco use or tobacco use within the past year.
- Exposure to an investigational study drug within the past 12 months.
- Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Wheaton, Maryland, 20902, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Camperdown, New South Wales, 2050, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Toorak Gardens, South Australia, 5065, Australia
GSK Investigational Site
Clayton, Victoria, 3169, Australia
GSK Investigational Site
Melbourne, Victoria, 3004, Australia
GSK Investigational Site
Parkville, Victoria, 3052, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Mississauga, Ontario, L5A 1N1, Canada
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
GSK Investigational Site
Berlin, 13125, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Hamburg, 20249, Germany
GSK Investigational Site
Dobele, LV 3701, Latvia
GSK Investigational Site
Liepāja, LV3401, Latvia
GSK Investigational Site
Riga, LV1001, Latvia
GSK Investigational Site
Riga, LV1021, Latvia
GSK Investigational Site
Tukums, LV 3100, Latvia
GSK Investigational Site
Kaunas, LT-50009, Lithuania
GSK Investigational Site
Šiauliai, LT-76231, Lithuania
GSK Investigational Site
Vilnius, LT-01117, Lithuania
GSK Investigational Site
Vilnius, LT-08661, Lithuania
GSK Investigational Site
Vilnius, LT-09311, Lithuania
GSK Investigational Site
Auckland, 1311, New Zealand
GSK Investigational Site
Auckland, 1701, New Zealand
GSK Investigational Site
Grafton, 1001, New Zealand
GSK Investigational Site
Moscow, 123 182, Russia
GSK Investigational Site
Moscow, 123095, Russia
GSK Investigational Site
Moscow, 129010, Russia
GSK Investigational Site
Saint Petersburg, 190013, Russia
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2006
First Posted
February 9, 2006
Study Start
February 7, 2006
Primary Completion
July 1, 2006
Study Completion
July 4, 2006
Last Updated
April 13, 2018
Results First Posted
April 13, 2018
Record last verified: 2017-09
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.