Effect of Methacholine, Long-acting M-cholinolytic and beta2-agonist on the Binding Activity of Beta-receptors in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline beta-receptor binding activity at 60 min after the inhalation of formoterol or tiotropium.
研究概览
简要总结
Interventional open-labeled study in parallel groups is aimed to evaluate changes of beta receptors in healthy volunteers under the influence of inhaled metacholine, long-acting anticholinergics and beta-agonists using modified radioligand method.
详细描述
Long-acting beta2-agonists and anticholinergics are main drugs in therapy of chronic obstructive pulmonary disease . Beta-agonists exert their bronchodilatory effects via β2 adrenoceptors located on airway smooth muscle cells. Anticholinergics block mainly M3-cholinoreceptors located in the airways, thus inhibiting bronchoconstriction. Metacholine blocks M2-cholinoreceptors thus inducing bronchoconstriction. It is known, that muscarine and beta-receptors interact with each other, but the detailed mechanism is unknown. For evaluating the binding activity of beta-receptors after inhalation of these drugs the modified radioligand method was used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1 Provision of signed and dated informed consent form
- •Healthy male or female, aged 18-60 years
排除标准
- •Participants unable to perform spirometry
- •Exacerbation respiratory infection within the previous four weeks
- •Hypersensitivity or allergy to formoterol, metacholine or tiotropium bromide
- •Females who are currently pregnant and lactating
- •major surgery in the last 6 months
- •Refusal to participate
- •Currently participating in another clinical study
研究组 & 干预措施
smoking
Healthy smoking volunteers
干预措施: Formoterol (Drug)
smoking
Healthy smoking volunteers
干预措施: Tiotropium Bromide (Drug)
smoking
Healthy smoking volunteers
干预措施: metacholine test (Diagnostic Test)
non-smoking
Healthy non-smoking volunteers
干预措施: Formoterol (Drug)
non-smoking
Healthy non-smoking volunteers
干预措施: Tiotropium Bromide (Drug)
non-smoking
Healthy non-smoking volunteers
干预措施: metacholine test (Diagnostic Test)
结局指标
主要结局
Change from baseline beta-receptor binding activity at 60 min after the inhalation of formoterol or tiotropium.
时间窗: Baseline (pre-dose), 60 minutes
Beta-receptor binding activity will be measured with modified radioligand method before and after 60 min after the inhalation of formoterol or tiotropium
Change from baseline beta-receptor binding activity at 40 min after the challenge test with metacholine.
时间窗: Baseline (pre-dose), 40 minutes
Beta-receptor binding activity will be measured with modified radioligand method before and after 40 min after the challenge test with metacholine.
次要结局
- Comparison of beta-receptor binding activity measured with modified radioligand after formoterol and tiotropium.(Baseline (pre-dose), 60 minutes)
- Comparison of beta-receptor binding activity measured with modified radioligand method after formoterol or tiotropium in smokers and non-smokers.(Baseline (pre-dose), 60 minutes)
- Comparison of beta-receptor binding activity measured with modified radioligand after metacholine(Baseline (pre-dose), 40 minutes)
- Comparison of beta-receptor binding activity measured with modified radioligand method after inhalation of metacholine in smokers and non-smokers.(Baseline (pre-dose), 40 minutes)