Perennial Allergic Rhinitis Study In Pediatric Subjects
A Two Week Randomized, Double Blind Placebo Controlled, Parallel Group Study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in Pediatric Subjects With Perennial Allergic Rhinitis
1 other identifier
interventional
558
7 countries
66
Brief Summary
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
Shorter than P25 for phase_3
66 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 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 20, 2005
CompletedFirst Posted
Study publicly available on registry
April 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedJanuary 19, 2017
January 1, 2017
9 months
April 20, 2005
January 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.
Secondary Outcomes (1)
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of perennial allergic rhinitis.
You may not qualify if:
- Have significant concomitant medical conditions.
- Use of corticosteroids or other allergy medications during the study.
- Have abnormal ECG.
- Have laboratory abnormality.
- Have abnormal eye exam.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (66)
GSK Investigational Site
Costa Mesa, California, 92626, United States
GSK Investigational Site
Cudahy, California, 90201, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95819, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Shreveport, Louisiana, 71105, United States
GSK Investigational Site
Baltimore, Maryland, 21236, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Brick, New Jersey, 8724, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Liverpool, New York, 13090, United States
GSK Investigational Site
Rochester, New York, 14618, United States
GSK Investigational Site
Rochester, New York, 14627, United States
GSK Investigational Site
Utica, New York, 13502, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Bellevue, Pennsylvania, 15202, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Upland, Pennsylvania, 19013, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Knoxville, Tennessee, 37922, United States
GSK Investigational Site
Nashville, Tennessee, 37203-1424, United States
GSK Investigational Site
El Paso, Texas, 79902, United States
GSK Investigational Site
Buenos Aires, Buenos Aires, 1425, Argentina
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, 2000, Argentina
GSK Investigational Site
Santa Fe, Santa Fe Province, 3000, Argentina
GSK Investigational Site
Viña del Mar, Región de Valparaíso, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Joensuu, 80100, Finland
GSK Investigational Site
Nokia, 37100, Finland
GSK Investigational Site
Tampere, 33200, Finland
GSK Investigational Site
Turku, 20610, Finland
GSK Investigational Site
Napoli, Campania, 80138, Italy
GSK Investigational Site
Bari, 70124, Italy
GSK Investigational Site
Milan, 52-20129, Italy
GSK Investigational Site
Monticelli Ascoli Piceno, 63100, Italy
GSK Investigational Site
Perugia, 06126, Italy
GSK Investigational Site
Salerno, 84100, Italy
GSK Investigational Site
México, 04530, Mexico
GSK Investigational Site
México, 6720, Mexico
GSK Investigational Site
Monterrey, N.L, 64460, Mexico
GSK Investigational Site
Banská Bystrica, 974 01, Slovakia
GSK Investigational Site
Bratislava, 821 06, Slovakia
GSK Investigational Site
Levoča, 054 01, Slovakia
GSK Investigational Site
Nitra, 949 01, Slovakia
Related Publications (3)
Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).
RESULTMáspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.
RESULTMaspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023.
PMID: 18164990RESULT
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2005
First Posted
April 21, 2005
Study Start
February 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
January 19, 2017
Record last verified: 2017-01
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.