NCT00445510已完成2 期
A Double Blind, Placebo Controlled, Repeat Dose Study to Determine the Effect of GSK256066 87.5 Mcg to Protect Against AMP Challenge in the Lung in Mild Steroid-naive Asthmatics.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.
研究概览
简要总结
This will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066 on bronchial hyper-reactivity to adenosine monophosphate.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion: (All must Apply)
- •Males and females aged 18 to 55 years inclusive.
- •Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
- •Pre-bronchodilator FEV1 >75% of predicted at screening.
- •Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of <80 mg/ml at the screening visit.
- •Demonstrate stable bronchoconstriction in response to inhaled AMP at the run-in visit. 'Stable bronchoconstriction' is a term to define a population of asthmatics who have a repeatable and reproducible response to a challenge agent that induces bronchoconstriction. The run-in PC20 needs to be within 1.25DD of the screening PC
- •Non-smoking status as verified by urinary cotinine levels below 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >6 months and have less than a 5 pack-year smoking history.
- •Able and willing to give written informed consent to take part in the study.
- •Available to complete all study measurements.
排除标准
- •Pregnant or nursing females.
- •Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- •Subject has known history of hypertension or is hypertensive at screening.
- •Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- •History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
- •Unable to abstain from prescription medication, other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments eg headache from 48h before the first dose until the follow-up visit.
- •The subject has participated in a clinical trial during the previous 3 months.
- •History of blood donation (450 mL) within 2 months of starting the clinical study.
- •The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female.
- •The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen or HIV antibodies.
- •The subject has positive drugs of abuse test.
- •Subjects weighing less than 50kg are to be excluded from participating in the study.
结局指标
主要结局
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.
次要结局
- AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 24hrs post-dose on Day 7. Exhaled Nitric Oxide: GSK256066 7 days of 87.5mcg vs placebo at Day 1; 1hr and 2hr, Day 7; 1hr, 2hr and 24hr.
研究者
研究点 (1)
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