A Study To Evaluate The Efficacy And Safety Of A 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 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
1 other identifier
interventional
288
2 countries
49
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 Jan 2005
Shorter than P25 for phase_3
49 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
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 8, 2005
CompletedFirst Posted
Study publicly available on registry
February 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedSeptember 19, 2016
September 1, 2016
4 months
February 8, 2005
September 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 PAR symptoms.
Secondary Outcomes (1)
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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 medications and some other medications during the study.
- Current tobacco use.
- Clinically significant abnormal ECG or laboratory abnormality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (49)
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Vero Beach, Florida, 32960, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Lilburn, Georgia, 30047, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Portland, Maine, 04102, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Rockville, Maryland, 20850, United States
GSK Investigational Site
North Andover, Massachusetts, 01845, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Springfield, Massachusetts, 01107, United States
GSK Investigational Site
St Louis, Missouri, 63104, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Lincoln, Nebraska, 68505, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Summit, New Jersey, 07091, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Nashville, Tennessee, 37203-1424, United States
GSK Investigational Site
Austin, Texas, 78731, United States
GSK Investigational Site
New Braunfels, Texas, 78130, United States
GSK Investigational Site
Murray, Utah, 84107, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
West Allis, Wisconsin, 53227, United States
GSK Investigational Site
Kelowna, British Columbia, V1Y 9L8, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E1, Canada
GSK Investigational Site
Mississauga, Ontario, L5A 1N1, Canada
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2, Canada
GSK Investigational Site
Québec, Quebec, G1V 4M6, Canada
GSK Investigational Site
Saskatoon, Saskatchewan, S7H 0V1, Canada
Related Publications (2)
Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy
RESULTNathan RA, Berger W, Yang W, Cheema A, Silvey M, Wu W, Philpot E. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008 May;100(5):497-505. doi: 10.1016/S1081-1206(10)60477-2.
PMID: 18517084DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
February 8, 2005
First Posted
February 9, 2005
Study Start
January 1, 2005
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
September 19, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share