NCT01316315已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Two-Period, Cross-Over Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing
研究概览
简要总结
The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.
详细描述
The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at screening.
- •Patient has a ≤ 5 pack years smoking history and nonsmoking for ≥ one year.
- •Documented history of mild bronchial asthma, first diagnosed at least 6 months and currently being treated only with intermittent short-acting beta-agonist therapy by inhalation.
- •Pre-bronchodilator FEV1 ≥ 75% of predicted at screening.
- •Sensitivity to methacholine with a provocation concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of ≤ 8 mg/ml at screening.
- •Demonstrated stable lung function during screening with ≤10% variability between two assessments of FEV1 taken at least 7 days apart at approximately the same time of day.
排除标准
- •Hypertension at screening is defined as systolic blood pressure (BP) >150 mmHg or diastolic BP > 90mmHg.
- •Respiratory tract infection and/or exacerbation of asthma within prior 4 weeks
- •History of life-threatening asthma
- •Administration of steroids within 4 weeks of the screening visit.
- •History of being unable to tolerate or complete MCh testing.
- •Blood donation (500 mL) within 3 months of starting the clinical study.
- •Tested positive for hepatitis C antibody or hepatitis B surface antigen.
- •Tested positive for human immunodeficiency virus (HIV) antibodies.
研究组 & 干预措施
Active
Experimental
N6022 - 5 mg
干预措施: Active (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing
时间窗: 24 hours
These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.
次要结局
- Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing(8 hours)
- To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.(10 Weeks)
研究者
研究点 (2)
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