An 8 Day, Randomised, Double Blinded, Placebo-controlled 2-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Placebo in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
研究概览
简要总结
This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD.
Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used.
This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.
12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is healthy.
- •They are aged 18 to 50 years inclusive.
- •Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
- •They have a history of seasonal allergic rhinitis
- •They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber,
- •They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
- •They have a positive RAST for grass pollen at or within the 12 months preceding the screening visit.
- •They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit
- •They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum recorded value)/ FVC (associated value)>70% predicted.
排除标准
- •Pregnant or nursing females.
- •Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
- •any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection.
- •The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
- •The subject has a history of drug or other allergy
- •The subject is concurrently participating in another clinical study in the past 3 months
- •A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening
- •A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- •The subject has donated a unit of blood within the previous 3 months.
结局指标
主要结局
Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)
时间窗: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7
次要结局
- Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)(1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.)