Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Terbutaline concentrations in serum and urine
研究概览
简要总结
The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.
详细描述
To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline.
To investigate the above mentioned in 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
- Crossover
- 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 visit 1 and
- •Subjects with other chronic diseases than asthma and allergy.
- •Allergy towards the study medicine.
- •Use of beta-2-agonist 6 days prior to study day.
研究组 & 干预措施
asthmatics
10 male asthmatic subjects
干预措施: inhaled and oral terbutaline (Drug)
healthy
10 male healthy volunteers
干预措施: inhaled and oral terbutaline (Drug)
elite athletes with asthma
10 elite athletes with asthma.
干预措施: inhaled and oral terbutaline (Drug)
结局指标
主要结局
Terbutaline concentrations in serum and urine
时间窗: baseline, 4, 8, and 12 hours after medicine administration
次要结局
未报告次要终点