Long Term Safety Of GW685698X Via Nasal Biopsy
A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects 18 Years of Age With Perennial Allergic Rhinitis (PAR)
1 other identifier
interventional
125
2 countries
4
Brief Summary
Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2005
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedOctober 28, 2016
October 1, 2016
1.4 years
August 26, 2005
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
Secondary Outcomes (1)
No Secondary Outcome Measures
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
- Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control.
You may not qualify if:
- Patients who require certain medications for their allergy.
- Patients with serious medical problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (4)
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site
Nijmegen, 6525 EX, Netherlands
GSK Investigational Site
The Hague, 2566 MJ, Netherlands
Related Publications (1)
Fokkens W, Hellings P, Blom H, Jansen A, van Drunen K, Clements D, Wu W, Caldwell M, Philpot E. A comparison of the effects of fluticasone furoate and mometasone furoate nasal sprays on the nasal mucosa. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A12 (abstract)
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2005
First Posted
September 23, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
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.