A Proof of Concept Study to Evaluate the Trough Bronchoprotection Conferred by Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- methacholine challenge
研究概览
简要总结
The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.
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
- Double (Participant, Investigator)
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
- •Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20< 4 mg/ml
- •>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
- •Male or female 18-65
- •Informed Consent
- •Ability to comply with the requirements of the protocol
排除标准
- •Severe asthmatics as defined by an FEV1≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
- •The use of oral corticosteroids within the last 3 months.
- •Recent respiratory tract infection (2 months).
- •Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
- •Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA, that may endanger the health or safety of the participant, or jeopardise the protocol.
- •Any significant abnormal laboratory result as deemed by the investigators
- •Pregnancy, planned pregnancy or lactation
- •Known or suspected contra-indication to any of the IMP's
- •Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
研究组 & 干预措施
levosalbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
干预措施: levosalbutamol (Drug)
2: racemic salbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
干预措施: racemic salbutamol (Drug)
3: Placebo
Patients will be asked to take two puffs four times a day for 2 weeks
干预措施: placebo (Drug)
结局指标
主要结局
methacholine challenge
时间窗: before and after 2 week study period
次要结局
- spirometry(before and after 2 week study period)
- symptom scores(before and after 2 week study period)
- nitric oxide levels(before and after 2 week study period)
- Bmax and Emax(before and after 2 week study period)
研究者
Brian J Lipworth
Professor
University of Dundee