NCT00914654Unknown4 期
Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum and urine concentrations of formoterol
研究概览
简要总结
The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol.
详细描述
The purpose of the study is to assess the serum and urine concentrations after inhalation of 18 microgram formoterol as one dose.
Furthermore to investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Physician-diagnosed asthma with positive reversibility or challenge test.
- •Informed consent.
- •Age between 18-45 years.
- •Sex: male.
- •Asthma classified as mild to moderate according to GINA guidelines.
- •Used beta-2-agonist in minimum 12 months.
排除标准
- •Smokers or ex-smokers with a smoking history of 10 pack years or more.
- •Respiratory tract infections within the last 2 weeks prior to study day.
- •Subjects with other chronic diseases than asthma and allergy.
- •Allergy towards the study medicine.
- •Use of beta-2-agonist 10 days prior to study day.
研究组 & 干预措施
Healthty
Other
10 healthy men
干预措施: inhaled formoterol (Drug)
Asthmatics
Other
10 male asthmatic subjects
干预措施: inhaled formoterol (Drug)
Elite asthmatics
Other
10 male elite athletes with asthma
干预措施: inhaled formoterol (Drug)
结局指标
主要结局
Serum and urine concentrations of formoterol
时间窗: baseline, 4, 8, and 12 hours after medicine administration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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