Last updated: 11/04/2018 06:58:38

A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (year-round) Allergic Rhinitis

GSK study ID
FFR110537
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Cumulative proportion (CU) of participants (par.) with an event, as measured as a percentage, for posterior subcapsular opacity (P)

Timeframe: 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

Timeframe: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104

Secondary outcomes:

Change from baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104

Timeframe: 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

Timeframe: Baseline, Week 52, and Week 104

Change from baseline in LOCS III cortical opacity (C) at Week 52 and Week 104

Timeframe: 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

Timeframe: Baseline, Week 52, and Week 104

Change from baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104

Timeframe: Baseline, Week 52, and Week 104

Change from baseline in Nuclear Color (NC) at Week 52 and Week 104

Timeframe: Baseline, Week 52, and Week 104

Change from baseline in intraocular pressure (IOP) at Weeks 52 and 104

Timeframe: Baseline, Week 52, and Week 104

Number of participants with the indicated change from baseline in intraocular pressure (IOP) by increments of 1 mm Hg at Week 52

Timeframe: Baseline and Week 52

Number of participants with the indicated change from baseline in intraocular pressure (IOP) by increments of 1 mm Hg at Week 104

Timeframe: Baseline and Week 104

Change from baseline in logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity (VA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at Week 52 and Week 104

Timeframe: Baseline, Week 52, and Week 104

Percent change from baseline in the funduscopic horizontal cup-to-disc ratio at Week 104

Timeframe: Baseline and Week 104

Change from baseline in the daily reflective total nasal symptom score (rTNSS) for the indicated study periods

Timeframe: Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104

Interventions:
Drug: fluticasone furoate nasal spray
Drug: vehicle placebo nasal spray
Enrollment:
550
Observational study model:
Not applicable
Primary completion date:
2011-18-02
Time perspective:
Not applicable
Clinical publications:
LaForce C, Journeay GE, Miller SD, Silvey MK, Wu W, Lee LA, Chylack Jr LT. Ocular safety of fluticasone furoate nasal spray in patients with perennial allergic rhinitis: a 2-year study. Ann Allergy Asthma Immunol. 2013;
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
June 2008 to February 2011
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Subjects eligible for enrollment in the study must meet all of the following criteria:
  • Informed consent
  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Significant concomitant medical conditions, defined as but not limited to:

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95678
Status
Study Complete
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78750
Status
Study Complete
Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oxford, Alabama, United States, 36203
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Waco, Texas, United States, 76712
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68130
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
El Paso, Texas, United States, 79903
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Canton, Ohio, United States, 44718
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Conyers, Georgia, United States, 30013
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Sylvania, Ohio, United States, 43560
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
Status
Study Complete
Location
GSK Investigational Site
Summerville, South Carolina, United States, 29485
Status
Study Complete
Location
GSK Investigational Site
Bozeman, Montana, United States, 59718
Status
Study Complete
Location
GSK Investigational Site
Ocean, New Jersey, United States, 07712
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Eugene, Oregon, United States, 97401
Status
Study Complete
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68131
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Jose, California, United States, 95117
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2011-18-02
Actual study completion date
2011-18-02

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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