A Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Safety and Efficacy of ONO-6950 20 mg and 200 mg QD Versus Placebo and Montelukast (Singulair) in Asthmatic Patients Who Experience Exercise-induced Bronchoconstriction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 9
- 主要终点
- Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
研究概览
简要总结
The primary objectives of this study are:
i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge
ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ONO-6950 in asthmatic patients.
The secondary objectives of this study are:
i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise challenge
ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.
详细描述
The study will examine if ONO-6950 could alleviate EIB in asthmatic patients. Eligible patients will complete a randomized, double-blind, four-way crossover study. During each of four evaluation periods, patients will be administered a single dose of either 20 or 200 mg ONO-6950, 10 mg Montelukast, or placebo. Each evaluation period include various assessments following exercise challenge in an ambulatory setting.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders, between 18 to 60 years of age, with bronchial asthma for at least 6 months and history of exercise induced bronchospasm
- •Patients with FEV1 ≥ 70% of predicted after withholding short-acting β agonists for at least 8 hours prior to testing
- •Screening exercise challenge demonstrates that the patient experiences a fall in FEV1 of ≥ 20%
- •Non-smokers with free from the usage of nicotine-containing products at least for a year prior to screening
排除标准
- •Previous history of life-threatening asthma, respiratory tract infection and/or exacerbation of asthma within 6 weeks prior to the first screening visit
- •History of being unable to tolerate or complete an exercise challenge and clinically significant multiple drug or food allergies
- •Past or present disorders and diseases including, but are not limited to cardiovascular, malignancy, hepatic, renal, hematological, neurological, psychiatric, endocrine, or pulmonary other than asthma
- •Patients with Seasonal Allergic Rhinitis (SAR) or seasonal allergic asthma,with significant symptoms that may confound study assessment
- •Significant safety laboratory, ECG, or vital sign abnormalities that would place the patient at undue risk during the study procedures
研究组 & 干预措施
Experimental 200 mg dose
干预措施: ONO-6950 (Drug)
Experimental 20 mg dose
干预措施: ONO-6950 (Drug)
Active Comparator Montelukast
干预措施: Montelukast (Drug)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Inhibition of maximum fall in Forced Expiratory Volume in One Second (FEV1) after exercise
时间窗: 60 minutes following the exercise challenge
次要结局
- AUC (0-30 min)(30 minutes following the exercise challenge)
- AUC (0-60 min)(60 minutes following the exercise challenge)
- Time to recovery of FEV1 to within 5% of the pre-exercise baseline(90 minutes following the exercise challenge)
- Proportion of patients using a short acting beta agonist (rescue medication)(90 minutes following the exercise challenge)
- Ratio of responder/non-responder in FEV1(60 minutes following the exercise challenge)