A Comparison of Clinic-based Versus Home-based Spirometry.
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- 2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device.
研究概览
简要总结
The study aims to assess the differences between spirometry performed with the NuvoAir Air Next spirometer in the clinic setting with both direct and virtual supervision via a video call, and in the home setting with virtual supervision. This is will be achieved by comparing lung function values, specifically the FEV1 and FVC measurements. We also wish to evaluate participant's perceptions of home spirometry, by using a survey.
This is a multi-centre, cross-over study. The study will enrol participants with a diagnosis of asthma and COPD, across participating study sites until 68 have completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An ability to provide fully informed consent.
- •A diagnosis of asthma or COPD.
- •Male or female aged ≥18 and ≤ 80 years of age.
排除标准
- •Symptoms suggestive of COVID-
- •An exacerbation of asthma or COPD or symptoms of a respiratory infection within the 30 days prior to the first visit.
- •Any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the Investigator(s), to impact on the ability to participate in the study.
- •The presence of any contraindications to spirometry.
研究组 & 干预措施
Clinic vs Home spirometry
The collection of medical history and demographic data Spirometry testing in both the clinic and home setting. The measurement of height and weight. The evaluation of the perception of home spirometry via a survey.
干预措施: NuvoAir Air Next spirometer (Device)
结局指标
主要结局
2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device.
时间窗: 8 days
The forced expiratory volume in 1 second (FEV1) and forced vital Capacity (FVC) will be measured via the NuvoAir Air Next spirometer at home at 2 points during the 8 day study period.
1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home.
时间窗: 8 days
Over an 8-day period; the forced expiratory volume in 1 second (FEV1) and forced vital Capacity (FVC) will be measured at 4 points in the study over the 8 day study period. Twice in clinic and twice at home.
次要结局
- To evaluate the participant's views of home spirometry via a survey.(8 days)