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
Overview
- Phase
- Phase 4
- Intervention
- fluticasone furoate nasal spray
- Conditions
- Rhinitis, Allergic, Perennial
- Sponsor
- GlaxoSmithKline
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •12 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)
Exclusion Criteria
- •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,
- •NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
- •Rhinitis medicamentosa
Arms & Interventions
fluticasone furoate nasal spray
Intervention: fluticasone furoate nasal spray
vehicle placebo nasal spray
Intervention: vehicle placebo nasal spray
Outcomes
Primary Outcomes
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
Time Frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
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.
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
Time Frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
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.
Secondary Outcomes
- 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 Nuclear Opacity (NO) at Week 52 and Week 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 Nuclear Color (NC) at Week 52 and Week 104(Baseline, Week 52, and Week 104)
- Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104(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 104(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(Baseline, Week 52, and Week 104)
- Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104(Baseline and Week 104)
- Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods(Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104)
- Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52(Baseline and Week 52)