A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older With Perennial Allergic Rhinitis
1 other identifier
interventional
550
1 country
56
Brief Summary
The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed 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_4
Started Jun 2008
Typical duration for phase_4
56 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
May 20, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
March 13, 2012
CompletedJanuary 13, 2017
November 1, 2016
2.7 years
May 20, 2008
December 8, 2011
November 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.
Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.
Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Secondary Outcomes (12)
Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104
Baseline, Week 52, and Week 104
Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104
Baseline, Week 52, and Week 104
Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104
Baseline, Week 52, and Week 104
Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104
Baseline, Week 52, and Week 104
Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104
Baseline, Week 52, and Week 104
- +7 more secondary outcomes
Study Arms (2)
vehicle placebo nasal spray
PLACEBO COMPARATORfluticasone furoate nasal spray
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects eligible for enrollment in the study must meet all of the following criteria:
- \- Informed consent
- Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
- Outpatient
- Subject is treatable on an outpatient basis.
- Age
- years of age and older at Visit 2
- Male or eligible female Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
- To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
- Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
- Oral contraceptive (either combined estrogen/progestin or progestin only)
- Injectable progestogen
- Implants of levonorgestrel
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
- +13 more criteria
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Significant concomitant medical conditions, defined as but not limited to:
- A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
- History or current diagnosis of diabetes mellitus
- Uncontrolled hypertension (i.e., systolic blood pressure ³ 140mm Hg or diastolic blood pressure ³ 90mm Hg)
- A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug
- Nasal (e.g., nasal septum) or ocular injury/surgery in the last 6 months (including LASIK eye surgery)
- Asthma, with the exception of mild intermittent asthma \[National Asthma Education and Prevention Program (NAEPP) Guidelines for the Diagnosis and Management of Asthma - Expert Panel Report 3, National Institutes of Health, August 28, 2007.
- NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
- Rhinitis medicamentosa
- Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
- Current or history of glaucoma and/or ocular herpes simplex
- Current cataract and/or previous history of cataract surgery
- Physical impairment that would affect subject's ability to participate safely and fully in the study
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (56)
GSK Investigational Site
Oxford, Alabama, 36203, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Los Angeles, California, 90025, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Roseville, California, 95678, United States
GSK Investigational Site
Sacramento, California, 95823, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Jose, California, 95117, United States
GSK Investigational Site
Stockton, California, 95207, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Conyers, Georgia, 30013, 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
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Bozeman, Montana, 59718, United States
GSK Investigational Site
Bellevue, Nebraska, 68123-4303, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
Asheville, North Carolina, 28801, 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
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Summerville, South Carolina, 29485, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231-4307, United States
GSK Investigational Site
El Paso, Texas, 79903, United States
GSK Investigational Site
Kerrville, Texas, 78028, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
Related Publications (1)
LaForce C, Journeay GE, Miller SD, Silvey MJ, Wu W, Lee LA, Chylack LT Jr. Ocular safety of fluticasone furoate nasal spray in patients with perennial allergic rhinitis: a 2-year study. Ann Allergy Asthma Immunol. 2013 Jul;111(1):45-50. doi: 10.1016/j.anai.2013.04.013. Epub 2013 May 12.
PMID: 23806459BACKGROUND
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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2008
First Posted
May 22, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
January 13, 2017
Results First Posted
March 13, 2012
Record last verified: 2016-11
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.