NCT00327808已完成2 期
Multi-Center, Randomized, Double-Blind, Repeated Doses Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
Syntara7 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 7
- 主要终点
- To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
研究概览
简要总结
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
详细描述
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 through 65 years of age.
- •Smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
- •Mild to moderate, stable, allergic asthma as defined by American Thoracic Society (ATS) criteria 1
- •History of episodic wheeze and shortness of breath
- •Subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
排除标准
- •History or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the Investigator
- •History of serious adverse reaction or hypersensitivity to corticosteroids
- •Abnormal chest X-ray that is judged clinically significant
- •Pregnant or lactating or have positive plasma pregnancy test
- •Use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
- •Use of any other asthma-related medications within 1 month of Screening
研究组 & 干预措施
Inhaler
Experimental
TPI 1020
干预措施: TPI-1020 (Drug)
Inhaler cortico.
Active Comparator
Budesonide inhaler
干预措施: budesonide (Drug)
结局指标
主要结局
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
时间窗: 22 days
次要结局
- To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22(22 days)
- To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14(22 days)
- To compare pre-dose FEV1 measurements on multiple days throughout the study(22 days)
- To compare peak flow measurements throughout the study(22 days)
- To compare the use of daily rescue medication (salbutamol) throughout the study(22 days)
- To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period(22 days)
研究者
研究点 (7)
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