A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy of Once-Daily Fluticasone Propionate Aqueous Nasal Spray 200mcg for 14 Days on Ocular Symptoms Associated With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)
研究概览
简要总结
This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history
- •Participants with diagnosis of seasonal allergic rhinitis
- •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.
- •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).
- •Participants with allergic rhinitis symptom of at least moderate severity for randomization:
- •An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline).
- •An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five days during the placebo lead in
- •Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period.
- •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.
排除标准
- •Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Participants with nasal disorders like:
- •injury or surgery to their nose that the investigator believes would interfere with participation in the study.
- •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.
- •Rhinitis medicamentosa
- •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.
- •Presence of or symptoms of an active bacterial or viral infection.
- •Participants who have conjunctivitis caused by an infectious agent.
- •Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months
研究组 & 干预措施
Fluticasone propionate nasal spray
Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.
干预措施: Fluticasone propionate (Drug)
Placebo nasal spray
Two sprays of placebo per nostril to be administered in morning.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)
时间窗: Baseline to 14 days
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.
次要结局
- Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning(Baseline to 14 days)
- Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores(Baseline to 14 days)
- Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms(Baseline to 14 days)
- Mean Change From Baseline in PM rTOSS(Baseline to 14 days)
- Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning(Baseline to 14 days)
- Mean Change in Objective Assessment of Conjunctival Redness(Baseline to 14 days)
- Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities(Baseline to 14 days)
- Mean Change From Baseline in AM rTOSS(Baseline to 14 days)
- Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering(Baseline to 14 days)
- Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering(Baseline to 14 days)
- Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness(Baseline to 14 days)
- Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)(Baseline to 14 days)
- Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness(Baseline to 14 days)
- Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)(Baseline to 14 days)
- End-of-treatment Assessment of Response to Therapy for Ocular Symptoms(Day 14)
- Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems(Baseline to 14 days)
- Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms(Baseline to 14 days)
- Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms(Baseline to 14 days)