A randomized, open-label, three-way crossover study tovalidate the SpirofyTM device (Cipla, pneumotach sensorbased spirometer) by comparing two SpirofyTM deviceswith the reference Vitalograph Alpha Touch standardspirometer (pneumotach sensor-based conventionalspirometer) in healthy, asthmatic and COPD subjects

Cipla Limited0 个研究点目标入组 90 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•Subjects meeting the below mentioned criteria will be enrolled in the study:
•1. Healthy subjects or stable asthma patients or stable COPD patients
•2. Age Ã¢â?°Â¥18 years
•3. Medical history / medical records showing evidence of diagnosed asthma or COPD for
•these patients.
•4. No history of exacerbations of any disease since last 4 weeks
•5. No active or chronic respiratory complaints, normal clinical examination and normal
•spirometry for healthy individuals.
•6. No history of upper or lower respiratory tract infection since last 4 weeks
•7. Subjects able to perform spirometry in accordance to 2019 ATS/ERS criteria with a
•grading between A Ã¢â?¬â?? B
•8. COVID-19 test report negative within the last 24 to 48 hours or as per site instituteÃ¢â?¬•s
•policy and free from any active symptoms suggestive of COVID-19

•1. Significant lung/airway diseases other than the asthma or COPD diagnosis for each of
•the subject groups
•2. Any contraindications for spirometry as per ATS/ERS 2019 Guidelines as mentioned in
•section 4.4 of the protocol.
•3. Any significant deformity of the thorax or vertebral column that may cause persistent
•airflow limitation or altered lung volumes
•4. Uncontrolled or unstable asthma / COPD status in the subjects
•5. Severe concomitant disease which may have an adverse 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

发起方