A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The tolerability to sputum induction test
研究概览
简要总结
Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways.
However, the procedure can be slightly uncomfortable for patients. This study aims to assess the differences in participants' tolerability of sputum induction, by comparing two different nebulisers when performing the procedure.
详细描述
This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.
If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in the event of unsuccessful procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an ability to provide fully informed consent.
- •Have a diagnosis of asthma or COPD.
- •Male or female.
- •Age between 18 to 75 years.
排除标准
- •Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
- •Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
- •Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
- •Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
研究组 & 干预措施
Omron
Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.
干预措施: Omron NE-U17 Ultrasonic nebuliser (Device)
Omron
Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.
干预措施: Akita Jet Inhalation System (Device)
Akita
Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
干预措施: Omron NE-U17 Ultrasonic nebuliser (Device)
Akita
Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
干预措施: Akita Jet Inhalation System (Device)
结局指标
主要结局
The tolerability to sputum induction test
时间窗: During the visit, after each cycle of nebulisation (each 5 minutes)
Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)
次要结局
- Saline quantity(During the visit, up to 30 minutes)
- Spirometry(During the visit, up to 4 hours)
- Borg Scale(During the visit, up to 4 hours)
- The quality of sputum samples(During the processing time, 2 hours)
- The quantity of sputum samples(During the visit, up to 4 hours)
- Time to produce sample(During the visit, up to 30 minutes)
- Influence of Physiotherapy techniques(During the study visit, up to 5 minutes)