A randomized, open-label, three side crossover study investigator initiated study to validate the i-Spiro (Cipla) by comparing Cipla Pneumotach sensor based spirometer and Koko spirometer (pneumotach sensor which is based on conventional spirometer) in healthy adult subjects, adult patients having asthma and adult patients having Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Difference in FVC and FEV1 value measured by the Koko Spirometer and the iSPiro is not more than 500 ml and 350 ml respectively.
研究概览
简要总结
This is an investigator initiated study to compare the iSpiro (spirometer manufactured by Cipla Ltd.) with the conventional Koko spirometer used in routine clinical practice. This study will be done in 81 participants which include healthy adult volunteers, adult asthmatic patients and COPD patients. This is a randomized, open-label, three-way crossover investigator initiated study.
The primary objective is to validate the i-Spiro (Cipla) by comparing Cipla Pneumotach sensor based spirometer and Koko spirometer used in clinical practice. The secondary objective of this study is to assess the intra-instrument variability and inter-instrument variability of the i-Spiro (Cipla). The study hypothesis is that the iSpiro is as good as the conventional Koko spirometer with an estimated difference of 500 ml and 350 ml in Forced vital capacity and forced expiratory volume in the 1st second respectively.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy subjects or stable asthma patients or stable COPD patients 2.Subjects >18 years 3.Medical history / medical records for evidence of asthma and COPD.
排除标准
- •1.Acute exacerbation of bronchial asthma or COPD or hospitalization/emergency room visits due to asthma/COPD exacerbation within the last 6 weeks prior to study participation 2.History of any Abdominal/Thoracic surgery in the last 1 month 3.Any eye surgery in the last 1 month 4.Uncontrolled or unstable asthma and COPD status in the subjects 5.Severe concomitant disease which may have an impact on the spirometric performance such as any unstable health conditions viz cardiovascular, pulmonary, abdominal, neurological or any endocrine disorders 6.Female subject who is pregnant.
结局指标
主要结局
Difference in FVC and FEV1 value measured by the Koko Spirometer and the iSPiro is not more than 500 ml and 350 ml respectively.
时间窗: 24 hours
次要结局
- No significant difference in inter test and intra test values obtained(24 hours)