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
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    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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