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
Study complete
Study complete
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
    Primary completion date:
    2011-18-02
    Observational study model:
    Not applicable
    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
    Study complete
    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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