Assessment of Fluticasone Propionate on Ocular Allergy Symptoms

GlaxoSmithKline626 enrolled

Overview

This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).

While the current FP approved indication for GSK marketed formulation is limited to the treatment of nasal symptoms, several large well-controlled studies in which FP maintained adequate control of nasal symptoms when administered in a dose of 200 micrograms (mcg) once-daily (QD) also suggested improvement in ocular symptoms. This study will employ a randomized, double-blind, parallel group, multi-center design that compares FP and placebo nasal sprays in subjects with seasonal allergic rhinitis (SAR) to assess the effectiveness on ocular symptoms associated with AR.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

626

Conditions

Allergic Rhinitis Seasonal Allergic Rhinitis

Interventions

Fluticasone propionateDRUG

Nasal spray formulation (200 mcg/day)

PlaceboDRUG

Vehicle for Fluticasone propionate aqueous nasal spray

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history 2. Participants with diagnosis of seasonal allergic rhinitis 1. A clinical history (written or verbal confirmation) of allergic rhinitis with the seasonal onset and offset of nasal and ocular allergy symptoms during each of the last 2 mountain cedar pollen allergy seasons. 2. A positive skin test reaction to (at least) the relevant allergen, mountain cedar pollen, as determined by the skin pricks method performed within 12 months of Visit 1). 3. Participants with allergic rhinitis symptom of at least moderate severity for randomization: 1. An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline). 2. An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five days during the placebo lead in 4. Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period. 5. Participant demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent/assent and has received a signed and dated copy of the informed consent/assent form. Children, ages 12 to 17 will be required to sign an assent form as part of the informed consent process. Exclusion Criteria: 1. Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 2. Participants with nasal disorders like: 1. injury or surgery to their nose that the investigator believes would interfere with participation in the study. 2. previously diagnosed with a severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug. 3. Rhinitis medicamentosa 3. Participants who have historical or current evidence of clinically significant uncontrolled disease like asthma, cardiac arrhythmias, hypertension, diabetes mellitus, ocular herpes, glaucoma, hepatic or renal disease, malignancy etc. 4. Presence of or symptoms of an active bacterial or viral infection. 5. Participants who have conjunctivitis caused by an infectious agent. 6. Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months

Locations (1)

PPD Corporate Headquarters

Wilmington, North Carolina, United States

Outcomes

Primary Outcomes

Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)

The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.