A Pilot Study Into Health Pre and Post Treatment With Intravenous Aminophylline and Hydrocortisone in Severe Asthmatics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- To measure a significant improvement in lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
研究概览
简要总结
This study focuses on severe asthmatics and their asthma symptoms. 40% of asthma patients continue to experience symptoms and up to 5% of these have difficult-to-control asthma despite continually improving treatments. Severe asthmatics experience clinically-significant worse health-related quality of life than those than those with less severe asthma. Poorer health-related quality of life can be as a consequence of frequent, severe symptoms, which prevent the patient from continuing a normal, active lifestyle. The Royal Brompton Hospital uses the treatment regimen of intravenous (IV) Aminophylline and IV Hydrocortisone which appears to improve symptoms and reduce exacerbations. At present there is anecdotal evidence to support these assumptions. The objective of this study is to determine whether there is any objective evidence of improvement, in particular looking at lung function, symptoms and cardiovascular function.
详细描述
The participant will be involved in this project for approximately 3 - 4 weeks, depending on how long they usually come into hospital for, for clinical treatment. For 1 week they will wear a physical activity monitor before the first course of Aminophylline and Hydrocortisone, during the treatment, and for 1 more week post treatment. This monitor records how active the participants are and is a small monitor worn on the upper arm.
Both study visits will happen while the patients are already in hospital, on admission and on discharge and will take approximately 2-3 hours to complete.
Both study visits include:
• 3 types of breathing tests: Impulse oscillometry in the asthma laboratory, which means they will breath through a mouth piece in and out at a comfortable, steady rate.
Exhaled nitric oxide which measures gas produced by cells in the lungs. This is a comfortable, steady blow into a handheld machine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18-65 years
- •Diagnosis of severe asthma
- •Confirmed therapy adherence via serum Prednisolone and cortisol levels
排除标准
- •Mild and moderate asthma
- •Community acquired pneumonia
- •Acute porphyria
- •Pregnant and breast feeding women
- •Patients hypersensitive to ethylenediamine or allergic to the theophyllines, caffeine and/or theorbromine.
- •Patient with known hypersensitivity to components and in systemic fungal infection
- •Patients that are being administered live attenuated vaccines.
结局指标
主要结局
To measure a significant improvement in lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone
时间窗: Day 0 and Day 7 (+/- 3 days)
Lung function will be measured via spirometry (large airways) and impulse oscillometry (small airways) before and after treatment
次要结局
- To measure a significant improvement in symptoms in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone(Day 0 and Day 7 (+/- 3 days))
- To measure a significant improvement in quality of life in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone(Day 0 and Day 7 (+/- 3 days))
- To measure a significant improvement in exercise tolerance in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone(Day 0 and Day 7 (+/- 3 days))
- To measure a significant cardiovascular change in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone(Day 0 and Day 7 (+/- 3 days))